FLacs cost, benefit outweigh manual?

Cutting-edge Advancements
Clinical Diagnosis
Surgery
keratoconus:
Above, Beyond
standarD regime
April 1, 2017 Vol. 42, No. 6
Surgery
Drug therapy
FLACS cost, benefit
outweigh manual?
Yes. Use of FLACS
is supported
by consideration
of benefits, costs
Presenting
the debate
NO. Increased cost,
other limitations
overshadow potential
benefits of FLACS
By Cheryl Guttman Krader;
By Cheryl Guttman Krader;
Reviewed by Robert J. Cionni, MD
Reviewed by Rosa Braga-Mele, MD
though Further study is
needed to determine conclusively whether
or not femtosecond laser-assisted cataract
surgery (FLACS) is associated with better refractive outcomes compared with
conventional manual surgery, FLACS offers many other benefits that justify its
use, according to Robert J. Cionni, MD.
“There have been numerous peerreviewed studies and meta-analyses that
failed to demonstrate refractive outcome
superiority for FLACS compared with conventional cataract surgery,” said Dr. Cionni, medical director, The Eye Institute
of Utah, Salt Lake City.
On the other hand, some studies demonstrated better results for FLACS in terms of
quicker recovery, better refractive stability,
fewer higher-order aberrations, and even
in hitting the refractive target, he noted.
( Continues on page 30 : Yes, supported )
Femtosecond laser-assisted cat-
YOUR PATIENTS’ VISION
IS ONLY AS GOOD AS
THE IOL YOU CHOOSE.
In this next “Gloves Off with Gulani”
column, Arun C. Gulani, MD, continues
the discussion of viewing keratoconus
as a refractive anomaly that can be
brought to emmetropia rather than
one in which the cornea is worked
upon, or worse still, the topography
is corrected while the patient is left
with less-than-perfect vision. Various case scenarios—from complex
to staged management procedures—
are highlighted.
( See story on page 12 : Emmetropia )
Surgery
Dr. Cionni
medical director, The
Eye Institute of Utah,
Salt Lake City
aract surgery (FLACS) offers some advantages compared with a conventional
manual procedure, particularly for certain patients. Currently, however, FLACS
does not result in superior outcomes and
it has drawbacks that outweigh its benefits, according to Rosa Braga-Mele, MD.
“I am using FLACS, and I really like
it, but FLACS adds financial and clinical
challenges,” said Dr. Braga-Mele, professor of ophthalmology and vision sciences,
University of Toronto, Ontario.
Discussing cost, Dr. Braga-Mele noted
data from multiple studies show that, at
least initially, FLACS increases costs.
“Theoretically, the extra costs can be
passed on to the patient under certain
insurance exceptions or as a refractive
procedure,” she said. “However, I would
( Continues on page 31 : No, limitations )
Don’t just leave a lens. Leave a legacy.
Dr. Braga-Mele
making The
professor of
ophthalmology and
case for LASIK
vision sciences,
enhancementsStart yours with seamless
University of Toronto,
brilliance.
ophthalmologists must be prepared to perform corneal refractive
surgery enhancements after cataract
surgery—and LASIK is often the optimal choice, said Robert K. Maloney,
MD. Although only about 5.9% of patients require enhancements by laser
refractive surgery after advanced IOLs,
Dr. Maloney believes that’s enough to
push the envelope. “A 6% failure rate
is not a lot but it is enough to discourage a surgeon quickly,” he explained.
“A certain number of patients will need
touch-ups.”
( See story on page 24 : Enhancements )
Ontario
Find out how on page 5.
More than one way
to expand a pupil
Use of a pupil expansion device was able to produce
mydriasis safely without significant transillumination defects.
(Image courtesy of Brian A. Hunter, MD)
© 2017 Abbott Medical Optics Inc. | www.Vision.Abbott | PP2017CT0276
Read the article on page 26
OphthalmologyTimes.com
magenta
cyan
yellow unconventional
black
ES908681_OT040117_CVTP1_FP.pgs
03.30.2017
02:04
solutions Approaching medicine
like politicians isn’t accomplishing
much PAGE
6
ADV
CUTTING-EDGE ADVANCEMENTS
CLINICAL DIAGNOSIS
Surgery
KERATOCONUS:
ABOVE, BEYOND
STANDARD REGIME
SURGERY
( See story on page 12 : Emmetropia )
Surgery
MAKING THE
CASE FOR LASIK
ENHANCEMENTS
OPHTHALMOLOGISTS must be prepared to perform corneal refractive
surgery enhancements after cataract
surgery—and LASIK is often the optimal choice, said Robert K. Maloney,
MD. Although only about 5.9% of patients require enhancements by laser
refractive surgery after advanced IOLs,
Dr. Maloney believes that’s enough to
push the envelope. “A 6% failure rate
is not a lot but it is enough to discourage a surgeon quickly,” he explained.
“A certain number of patients will need
touch-ups.”
( See story on page 24 : Enhancements )
DRUG THERAPY
FLACS cost, benefit
outweigh manual?
YES. USE OF FLACS
IS SUPPORTED
BY CONSIDERATION
OF BENEFITS, COSTS
IN THIS NEXT “Gloves Off with Gulani”
column, Arun C. Gulani, MD, continues
the discussion of viewing keratoconus
as a refractive anomaly that can be
brought to emmetropia rather than
one in which the cornea is worked
upon, or worse still, the topography
is corrected while the patient is left
with less-than-perfect vision. Various case scenarios—from complex
to staged management procedures—
are highlighted.
April 1, 2017 VOL. 42, NO. 6
PRESENTING
THE DEBATE
NO. INCREASED COST,
OTHER LIMITATIONS
OVERSHADOW POTENTIAL
BENEFITS OF FLACS
By Cheryl Guttman Krader;
By Cheryl Guttman Krader;
Reviewed by Robert J. Cionni, MD
Reviewed by Rosa Braga-Mele, MD
THOUGH FURTHER STUDY is
needed to determine conclusively whether
or not femtosecond laser-assisted cataract
surgery (FLACS) is associated with better refractive outcomes compared with
conventional manual surgery, FLACS offers many other benefits that justify its
use, according to Robert J. Cionni, MD.
“There have been numerous peerreviewed studies and meta-analyses that
failed to demonstrate refractive outcome
superiority for FLACS compared with conventional cataract surgery,” said Dr. Cionni, medical director, The Eye Institute
of Utah, Salt Lake City.
On the other hand, some studies demonstrated better results for FLACS in terms of
quicker recovery, better refractive stability,
fewer higher-order aberrations, and even
in hitting the refractive target, he noted.
( Continues on page 30 : Yes, supported )
FEMTOSECOND laser-assisted catDr. Cionni
medical director, The
Eye Institute of Utah,
Salt Lake City
Dr. Braga-Mele
professor of
ophthalmology and
vision sciences,
University of Toronto,
Ontario
aract surgery (FLACS) offers some advantages compared with a conventional
manual procedure, particularly for certain patients. Currently, however, FLACS
does not result in superior outcomes and
it has drawbacks that outweigh its benefits, according to Rosa Braga-Mele, MD.
“I am using FLACS, and I really like
it, but FLACS adds financial and clinical
challenges,” said Dr. Braga-Mele, professor of ophthalmology and vision sciences,
University of Toronto, Ontario.
Discussing cost, Dr. Braga-Mele noted
data from multiple studies show that, at
least initially, FLACS increases costs.
“Theoretically, the extra costs can be
passed on to the patient under certain
insurance exceptions or as a refractive
procedure,” she said. “However, I would
( Continues on page 31 : No, limitations )
More than one way
to expand a pupil
Use of a pupil expansion device was able to produce
mydriasis safely without significant transillumination defects.
(Image courtesy of Brian A. Hunter, MD)
READ THE ARTICLE ON PAGE 26
OphthalmologyTimes.com
UNCONVENTIONAL SOLUTIONS Approaching medicine like politicians isn’t accomplishing much PAGE 6
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APRIL 1, 2017
contents
12
8
38
53
Special Report
Clinical Diagnosis
Practice Management
28 BENEFITS OF FLACS OVER
MANUAL CATARACT SUGERY
43 PATTERN, FLICKER ERG
TESTING FOR CATARACTS
50 IMPROVE CLINIC FLOW,
EASE EMPLOYEE TENSION
Visual acuity outcomes similar in study;
one procedure may yield better refractive
prediction than the other
In-office technologies reveal cell
functioning of disease with no need
for refraction, pattern recognition
In This Issue
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astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal
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APRIL 1, 2017 :: Ophthalmology Times
guest editorial
APRIL 1, 2017 ◾ VOL. 42, NO. 6
CONTENT
Unconventional times
Chief Medical Editor Peter J. McDonnell, MD
Is approaching medicine like a politician accomplishing much?
Content Specialist Jolie Higazi
[email protected] 440/891-2608
By Kim Wise, MD
Dr. Wise is in private practice in Norman, OK, and
specializes in LASIK and cataract surgery. A graduate
of the University of Oklahoma College of Medicine,
Dr. Wise received specialty training at the Dean McGee
Eye Institute. She has no financial disclosures relevant
to the subject matter.
I ENJOYED the recent blog post by
Donna Suter on take-away lessons from the
U.S. presidential election (OphthalmologyTimes.
com/PresidentialLessons). There are certainly
things on that list I need to improve on.
Perhaps there is another take-away lesson for
us. Whether one agrees or disagrees with President Donald J. Trump, we can agree that part
of his success was finding a way to skip the
media, go around the career politicians, and go
directly to the people.
Is it possible that our legislative efforts have
borne so little fruit because we’ve approached
it as a politician would? We send representatives to negotiate the old way, all the while losing more ground.
Let me be clear, lest I be misunderstood. I
certainly appreciate all the efforts that have
been made. No doubt we would be worse
off without them, but we do continue to lose
ground nonetheless. When you ask about certain things that could be corrected, typically,
the response is: “Well, this legislative stuff is
very complicated; that just can’t be done.”
No doubt I am ignorant as to the legislative
process and I welcome further education, but
it seems like a quick surrender. I realize that
dirty deals have to be made in Washington, DC.
I am not naïve. I’m just wondering if there’s a
different way.
C ON N E C T I NG DI R E C T LY
W I T H PAT IE N T S
Unconventional times call for unconventional
solutions. What if we were to connect directly
with our patients? How many of our patients
know what any of these letters mean (MIPS,
MACRA, PQRS)? And the impact on cost and
their privacy with little to no impact on the
quality of their care?
What do we suppose these patients would do
if they were given the data?
This will probably seem silly, but just go
with me. I wonder what would happen if you
could get most of the medical organizations,
and let’s say at least 50% of doctors, to hand
out a centrally produced document to explain
these programs from the physician standpoint.
To explain that these programs that push the
narrative of “quality” are nothing of the sort.
They are nothing more than intrusion and intervention that yield nothing except cost.
To explain all the bureaucrats employed to
run these programs.
To provide real numbers and explain how
many people could get actual coverage with the
money that is being spent on these programs.
To explain how excellent, experienced surgeons will shy away from challenging or difficult cases because they cannot afford for their
“quality rating” to drop.
To remind them that when the government has told them what they can expect from
healthcare, they’ve been misled in the past
(you can keep your doctor, you can keep your
plan, costs will go down).
And that maybe it wouldn’t be such a bad
thing to look to their actual physicians for
guidance.
Then refer them to a website that is thoughtful, noninflammatory, and simply explains the
facts, and suggests that if they agree with our
point of view they might want to contact their
legislators. We are loath to get political or to
draw fire and I completely appreciate that (I
am no different). We wanted to be doctors, not
politicians.
FIGHTING FOR OUR
PAT IE N T S
Perhaps if we do not think of this as a fight for
ourselves, but more of a fight for our patients
(and the doctors and patients of the future), we
might become more inspired.
One of a surgeon’s strong points is being
able to explain the reality of a procedure—both
good and bad—without pulling any punches to
help guide patients in their decision making.
What if we should apply that same skill
to the medical system at large? I cannot help
but wonder if our approaching medicine in
Washington, DC, like politicians isn’t getting
us exactly what politicians accomplish . . .
Not very much. Q
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deliver a favorable benefit-to-risk ratio. Studied extensively around the world, iStent has been implanted in
hundreds of thousands of eyes, and is backed by years of documented efficacy and safety data. For cataract
patients with open-angle glaucoma, start with the MIGS leader—and finish with leading performance.
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ASCRS Booth 847 800.GLAUKOS (452.8567) Glaukos.com
INDICATION FOR USE. The iStent® Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients
with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication. CONTRAINDICATIONS. The iStent® is contraindicated in eyes with primary or secondary angle closure glaucoma, including
neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy
should be performed prior to surgery to exclude PAS, rubeosis, and other angle abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a
hazard. The iStent® is MR-Conditional meaning that the device is safe for use in a specified MR environment under specified conditions, please see label for details. PRECAUTIONS. The surgeon should monitor the patient
postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent ® has not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes
with significant prior trauma, chronic inflammation, or an abnormal anterior segment, in pseudophakic patients with glaucoma, in patients with pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with
unmedicated IOP less than 22 mmHg or greater than 36 mmHg after “washout” of medications, or in patients with prior glaucoma surgery of any type including argon laser trabeculoplasty, for implantation of more than a
single stent, after complications during cataract surgery, and when implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract. ADVERSE EVENTS. The most common
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©2016 Glaukos Corporation. Glaukos and iStent are registered trademarks of Glaukos Corporation. 400-0370-2016-US Rev. 0
8
Special Report )
ASCRS
MEETING PREVIEW
ASCRS HITS ‘LA LA LAND’
FOR 2017 ANNUAL MEETING
Anterior segment specialists gear up for key lecture with astronaut Scott Kelly,
scientific updates, instructional courses, networking opportunities By Beth Thomas Hertz
Former NASA astronaut Scott Kelly—
who spent nearly a year on the International Space Station—will give the
ASCRS Lecture on Science, Medicine
and Technology at the annual meeting’s Sunday Summit, May 7, from 10
to 11 a.m.
Kelly is known for spending more
time in space than any other American.
He served two long-duration space station missions and two shorter-duration
shuttle missions between 1999 and 2015.
On his yearlong mission (March 2015
to March 2016), Kelly and Russian cos-
monaut Mikhail Kornienko conducted
experiments, reconfigured station modules, and educated the world from space.
Kelly will share life lessons and personal stories that provide valuable advice
on pushing one’s limits, the leadership
and teamwork required in demanding
conditions, and the challenges of his
experiences, according to ASCRS.
The Lecture on Science, Medicine and
Technology is designed to be a forum
for expanding and enriching appreciation of fields of science and medicine
beyond ophthalmology.
MEET ING OV ERV IEW
The annual meeting—held in conjunction with the American Society of Ophthalmic Administrators (ASOA)—is promoted as the largest U.S. meeting that
integrates a scientific program dedicated to the needs of the anterior segment specialist with a leading practice
management program for comprehensive ophthalmology and subspecialties.
Registration brings attendees access
to 1,300 ASCRS and ASOA presentations and online post-meeting resources.
The 2017 annual meeting also will
be a joint meeting with the Asia-Pacific
Association of Cataract and Refractive
Surgeons and will include a Technicians and Nurses Program from May
6 to 8, as well as special programming
and events for Young Eye Surgeons—a
group for residents, fellows, and surContinues on page 10 : ASCRS
take-home
Programming for this
year’s ASCRS meeting
promises quality
education for anterior
segment specialists,
practice managers,
and ophthalmic
technicians and
nurses.
Photo courtesy: Shutterstock / Sean Pavone
T
he 2017 meeting of the American Society of
Cataract and Refractive Surgery (ASCRS) will
be held May 5 to 9 at the Los Angeles Convention Center, but at least one guest speaker
will be sharing his “out-of-this-world” experiences.
Celebrating
UCLA Stein Eye Institute
Vision-Science Campus
Years of Vision
UCLA Stein Eye Institute opened its doors in November 1966. In its half century of progress,
the Institute has transformed into a vision-science campus — a dynamic West Coast presence
for patient care, research, and education.
Today, UCLA Stein Eye Institute encompasses three buildings on the UCLA Health Sciences
campus. In addition to vital programs at Harbor-UCLA Medical Center in Torrance, Olive
View-UCLA Medical Center in Sylmar and the VA Greater Los Angeles Healthcare System in
West Los Angeles, UCLA Stein Eye Institute has expanded its outreach with the opening of
the Stein Eye Center, Santa Monica and Doheny Eye Center UCLA locations in Arcadia,
Orange County and Pasadena.
We look forward to our next 50 years of preserving and restoring sight for the residents
of Southern California and beyond.
Proudly affiliated with the Doheny Eye Institute
100 Stein Plaza Dr., Los Angeles, CA 90095 (310) 825-5000 uclahealth.org/eye
APRIL 1, 2017 :: Ophthalmology Times
10
Special Report )
MEETING PREVIEW
ASCRS
ASCRS
On Friday, May 5, three full-day (8 a.m. to
5 p.m.) programs include:
( Continued from page 8 )
> ASCRS Glaucoma Day: Topics scheduled
for this event include “Special Considerations
for Phacoemulsification in Patients with PreExisting Open-Angle Glaucoma,” “Medications
and Lasers: Practical Concepts for Enhancing Glaucoma Care,” and “Making Sense of
the MIGS Revolution: A Practical Guide to the
Surgical Treatment of Glaucoma.” The 2017
Stephen A. Obstbaum, MD, Honored Lecture,
“The Holy Grail: Monitoring IOP 24/7,” will be
given by Marlene R. Moster, MD. Glaucoma Day
is sponsored by the ASCRS Glaucoma Clinical Committee.
geons with less than 5 years in practice. In addition to traditional presentations and sessions,
attendees also have access to roundtables, consultations, and legislative/regulatory updates.
The exhibit hall provides an additional opportunity to interact with more than 300 exhibitors. Visit Ophthalmology Times at booth 1803.
OTHER MEETING
HIGHLIGHTS
> The Opening General Session will be held
Saturday, May 6, from 10 to 11:45 a.m. The
> ASCRS Refractive Day: Topics for this
welcome will be given by ASCRS Program Chair Edward J. Holland, MD,
day will include cornea refractive
followed by the Presidents’ Adsurgery, refractive cataract surdresses. Kerry D. Solomon, MD,
gery, and refractive lens surgery.
will give the outgoing address
The Steinert Refractive Lecture,
To learn more about
and Bonnie An Henderson, MD,
“Challenges in IOL Calculations
the annual meeting
will give the incoming address.
with Post-Op and Ectatic Coror to register, visit
The Binkhorst Lecture, “Cataract
nea,” will be given by Douglas
Surgery in Small Pupils: Building
D. Koch, MD. Refractive Day is
The Bridge Over Troubled Waters,”
sponsored by the ASCRS Refractive
will be given by Boris Malyugin, MD,
Surgery Clinical Committee.
PhD, during this session. Dr. Malyugin is
a professor of ophthalmology at the European > Cornea Day: This event, sponsored by the
School for Advanced Studies in Ophthalmol- ASCRS Cornea Clinical Committee and the
ogy and is a board member of the European Cornea Society, will provide an overview of
Society of Cataract and Refractive Surgeons.
anterior segment surgery and corneal issues
Honored guests at the session will be Luther in cataract and refractive surgery. Topics inFry, MD, (ASCRS) and Y.C. Lee, MD (APACRS). clude corneal controversies and complications
Inductees into the ASCRS Ophthalmology Hall in cataract and refractive surgery, cornea ecof Fame Ceremony also will be honored. These tatic and ocular surface dilemmas, and cutinclude Karl Koller, MD, (deceased) and Gulla- ting-edge corneal surgery.
palli Rao, MD (India).
An ASCRS Foundation update also will be > Practice Management: A half-day pracgiven at the opening session.
tice management program, The John Pinto
> In addition to Kelly’s presentation, The Intensive Program for Surgeons: RegainSunday Summit will include a segment on “50 ing Control Over Your Practice’s Business
Years of Phaco: Origins, Obstacles and Accep- Affairs, also will be held on Friday from 1
tance.” This will be moderated by Dr. Holland. to 5 p.m. This program promises to address
> The Innovators General Session, set for pressing and practical aspects of ophthalmic
Monday from 10 to 11:30 a.m., will include the practice management from the ophthalmolo2017 Charles D. Kelman, MD, Innovator’s Lec- gist’s perspective.
ture. “Overcoming Resistance: Making Glaucoma a Surgical Disease” will be given by Reay
ASOA A NNUA L
H. Brown, MD.
MEETING
> The Best of ASCRS 2017 General Session Administrators and staff who attend the ASOA
will be held Tuesday from 1 to 2:30 p.m. This meeting will be able to choose from more than
wrap-up session will highlight some of the most 150 hours of presentations and educational
interesting papers from the annual meeting.
courses in topics that include MACRA and MIPS,
coding, reimbursement, human resources, information technology, marketing, and busiPR E-MEETING PROGR AMMING
Several specialized programs are offered be- ness operations.
Here are some highlights (some activities
fore the official start of the meeting. Separate
require separate registration):
registration is required.
LEARN MORE
www.ascrs.org
> Opening General Session: Achieving Peak
Performance: The keynote address in this 8
to 10 a.m. session will be given by Dan Thurmon, an author, entrepreneur, workplace performance expert, fitness advocate, acrobat, unicyclist, and drummer. His address will focus
on breaking the office culture out of the comfortable “box” of complacency. Thurmon reportedly uses gravity-defying feats as visual
aids to help deliver his message.
> Practice Management Bootcamp, 8 a.m.
to 5 p.m. Friday. Learn the basics of ophthalmic practice management in core areas, including chart documentation and audits, quality
measures and government regulations, financial management, working with technicians,
risk management, meeting today’s challenges,
and flow and efficiency to improve practice
performance.
> COE Review: Parts 1 and 2, Friday, 8 a.m. to
6 p.m., and Saturday, 1 to 6 p.m. Learn about
the six COE exam domains.
> The Ritz-Carlton Leadership Center: Excellence in The Patient Experience and Memorable Customer Service, Friday, 9 a.m. to 4:30
p.m. Learn how to develop a patient-centric
culture and gain insight into key processes
including onboarding, and employee and patient empowerment.
> Dale Carnegie Training: Building a Culture
of Engagement—Achieving and Retaining Success, Friday, 8 a.m. to 4 p.m. This session is
recommended for employees at all levels who
seek to maximize their performance, become
stronger leaders, and add more value to the
organization.
> The annual ASOA celebration will be held
Sunday from 8 p.m. to midnight at Exchange
LA, 618 S. Spring St., Los Angeles. ■
MARK YOUR CALENDAR
FOR THESE FUTURE
ASCRS/ASOA MEETINGS:
2018 April 13 to 17, Washington, DC
2019 May 3 to 7, San Diego
2020 May 15 to 19, Boston
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APRIL 1, 2017 :: Ophthalmology Times
surgery
Thinking outside the cone:
Over, above standard approach
Scenarios of keratoconus, management highlight ways to devise treatment ‘recipes’
Gloves Off with Gulani By Arun C. Gulani, MD
n this continuation that presents more
scenarios of keratoconus and their management, let’s first briefly recap the discussion in the previous “Gloves off with
Gulani” column, “Thinking outside the
cone: Keratoconus as a refractive surgery,” as well as some principles we
covered during the case discussion (Ophthalmology Times, Oct, 1, 2016, Page 16).
I
FIGURE 1
When we consider a condition such as keratoconus as a refractive disorder, the mindset then shifts from salvaging the eye to actually bringing it to visual excellence despite
the cone. We talked about various modalities,
concepts, and classification systems that I have
discussed over two decades, and we reviewed
some case scenarios in the previous column.
Therefore, I want to approach every case of
keratoconus with the mindset that the eye can
possibly reach the best visual outcome by using
all the available technologies and techniques,
performed singly or in staged combinations,
to the patient’s best advantage.
CASE SCENARIOS
FIGURE 1 In these case scenarios, I will quickly
review placement of Intacs segments (Addi-
FIGURE 2
84 to 28 u
3.7 to 0.3D
10.1 to 2.7D
Continues on page 14 : Scenarios
(All images courtesy Arun C. Gulani, MD)
FIGURE 4
FIGURE 3
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any lid hygiene regimen.
Antibiotic and resistance free Avenova
with Neutrox®. The one no-sting solution
that helps manage the itchy, burning,
irritated eyelids often caused by blepharitis,
MGD and dry eye. Used alone or
concomitantly, Avenova is the essential
part of any lid and lash hygiene regimen.
Avenova. Every day.
Daily lid and lash hygiene.
Avenova contains Neutrox, a proprietary pure hypochlorous acid that mimics the body’s immune response. It works without creating mammalian cell toxicity
or bacterial resistance. It’s well tolerated for daily use.
AV E N O VA . C O M
|
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R X O N LY
APRIL 1, 2017 :: Ophthalmology Times
14
surgery
FIGURE 5
Mean K Decrease 49 to 43 with stabilized
Astigmatism for Laser PRK in LASIK Ectasia
FIGURE 6
FIGURE 7
FIGURE 8
Before CXL
After CXL & CK
Pre-operation
Post-operation
CXL after ICL + Laser
SCENARIOS
( Continued from page 12)
tion Technology) using the Gulani-Donnenfeld concept of entry into the cornea at the
12 o’clock position, although the segment
placement still can be on the steep axis at
any orientation.
FIGURE 2 In such cases, even following placement of the Intacs segments, laser advanced
surface ablation (ASA) can be performed to
fine tune the refractive error to safely bring
the patient to emmetropia.
FIGURE 3 In these patients with ectasia, the
refractive error was controlled by asymmetric placement of the Intacs segments in a directional fashion to facilitate manipulation of
the cornea.
FIGURE 4 The Intacs can be used directionally to decrease the astigmatism. In this patient, the astigmatism is reduced from a preoperative value of 7.4 to 0.6 D, with a resultant immediate improvement in the vision.
There is also the potential for more visual
improvement later if laser ASA needs to be
performed.
FIGURE 5 Intacs segments can be implanted
not only to decrease the keratometry values
to a more normal range but also can be folContinues on page 17 : Cases
(All images courtesy Arun C. Gulani, MD)
Lasik Ectasia patient with INTACs: 20/400 BCVA
to 20/30 UCVA
The
®
PROLENSA Effect
POWERED FOR
PENETRATION
Advanced Formulation to Facilitate
Corneal Penetration1-3
PROLENSA® delivers potency and
corneal penetration with QD dosing
at a low concentration1-3
INDICATIONS AND USAGE
PROLENSA® (bromfenac ophthalmic solution) 0.07% is a
nonsteroidal anti-infl ammatory drug (NSAID) indicated
for the treatment of postoperative infl ammation and
reduction of ocular pain in patients who have undergone
cataract surgery.
IMPORTANT SAFETY INFORMATION ABOUT PROLENSA®
• PROLENSA® contains sodium sulfite, a sulfite that may
cause allergic type reactions including anaphylactic
symptoms and life-threatening or less severe asthmatic
episodes in certain susceptible people. The overall
prevalence of sulfite sensitivity in the general population is
unknown and probably low. Sulfite sensitivity is seen more
frequently in asthmatic than in non-asthmatic people.
• All topical nonsteroidal anti-inflammatory drugs (NSAIDs),
including bromfenac, may slow or delay healing.
Concomitant use of topical NSAIDs and topical steroids
may increase the potential for healing problems.
• There is the potential for cross-sensitivity to acetylsalicylic
acid, phenylacetic acid derivatives, and other NSAIDs,
including bromfenac. Use with caution in patients who
have previously exhibited sensitivities to these drugs.
• There have been reports that ocularly applied NSAIDs
may cause increased bleeding of ocular tissues (including
hyphemas) in conjunction with ocular surgery. Use with
caution in patients with known bleeding tendencies or
who are receiving other medications which may prolong
bleeding time.
PROLENSA is a registered trademark of Bausch & Lomb Incorporated or its affiliates.
© Bausch & Lomb Incorporated. All rights reserved. Printed in USA. PRA.0188.USA.15
• Use of topical NSAIDs may result in keratitis.
Patients with evidence of corneal epithelial breakdown
should immediately discontinue use of topical NSAIDs,
including bromfenac, and should be closely monitored
for corneal health. Patients with complicated ocular
surgeries, corneal denervation, corneal epithelial
defects, diabetes mellitus, ocular surface diseases
(e.g., dry eye syndrome), rheumatoid arthritis, or repeat
ocular surgeries within a short period of time may be
at increased risk for corneal adverse events which may
become sight threatening. Topical NSAIDs should be used
with caution in these patients. Post-marketing experience
with topical NSAIDs suggests that use more than 24 hours
prior to surgery or use beyond 14 days post-surgery may
increase patient risk for the occurrence and severity of
corneal adverse events.
• PROLENSA® should not be instilled while wearing contact
lenses. The preservative in PROLENSA®, benzalkonium
chloride, may be absorbed by soft contact lenses.
Lenses may be reinserted after 10 minutes following
administration of PROLENSA®.
• The most commonly reported adverse reactions in 3%-8%
of patients were anterior chamber inflammation, foreign
body sensation, eye pain, photophobia, and blurred vision.
Please see brief summary of full Prescribing Information
for PROLENSA® on adjacent page.
References: 1. PROLENSA Prescribing Information, April 2013. 2. Data on file, Bausch & Lomb Incorporated.
3. Baklayan GA, Patterson HM, Song CK, Gow JA, McNamara TR. 24-hour evaluation of the ocular distribution of
(14)C-labeled bromfenac following topical instillation into the eyes of New Zealand white rabbits. J Ocul Pharmacol Ther.
2008;24(4):392-398.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
This Brief Summary does not include all the information needed to prescribe
Prolensa safely and effectively. See full prescribing information for Prolensa.
PROLENSA (bromfenac opthalmic solution) 0.07%
Rx only
Initial Rx Approval: 1997
INDICATIONS AND USAGE
PROLENSA® (bromfenac ophthalmic solution) 0.07% is indicated for the treatment
of postoperative inflammation and reduction of pain in patients who have undergone
cataract surgery.
DOSAGE AND ADMINISTRATION
Recommended Dosing
One drop of PROLENSA ophthalmic solution should be applied to the affected eye
once daily beginning 1 day prior to cataract surgery, continued on the day of surgery,
and through the first 14 days of the postoperative period.
Use with Other Topical Ophthalmic Medications
PROLENSA ophthalmic solution may be administered in conjunction with other topical
ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase
inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5
minutes apart.
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Sulfite Allergic Reactions
Contains sodium sulfite, a sulfite that may cause allergic-type reactions including
anaphylactic symptoms and life-threatening or less severe asthmatic episodes in
certain susceptible people. The overall prevalence of sulfite sensitivity in the general
population is unknown and probably low. Sulfite sensitivity is seen more frequently in
asthmatic than in non-asthmatic people.
Slow or Delayed Healing
All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, may
slow or delay healing. Topical corticosteroids are also known to slow or delay healing.
Concomitant use of topical NSAIDs and topical steroids may increase the potential for
healing problems.
Potential for Cross-Sensitivity
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid
derivatives, and other NSAIDs, including bromfenac. Therefore, caution should be
used when treating individuals who have previously exhibited sensitivities to these
drugs.
Increased Bleeding Time
With some NSAIDs, including bromfenac, there exists the potential for increased
bleeding time due to interference with platelet aggregation. There have been
reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues
(including hyphemas) in conjunction with ocular surgery.
It is recommended that PROLENSA ophthalmic solution be used with caution in
patients with known bleeding tendencies or who are receiving other medications
which may prolong bleeding time.
Keratitis and Corneal Reactions
Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued
use of topical NSAIDs may result in epithelial breakdown, corneal thinning,
corneal erosion, corneal ulceration, or corneal perforation. These events may be
sight threatening. Patients with evidence of corneal epithelial breakdown should
immediately discontinue use of topical NSAIDs, including bromfenac, and should be
closely monitored for corneal health.
Post-marketing experience with topical NSAIDs suggests that patients with
complicated ocular surgeries, corneal denervation, corneal epithelial defects,
diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid
arthritis, or repeat ocular surgeries within a short period of time may be at increased
risk for corneal adverse events which may become sight threatening. Topical NSAIDs
should be used with caution in these patients.
Post-marketing experience with topical NSAIDs also suggests that use more than 24
hours prior to surgery or use beyond 14 days post-surgery may increase patient risk
for the occurrence and severity of corneal adverse events.
Contact Lens Wear
PROLENSA should not be instilled while wearing contact lenses. Remove
contact lenses prior to instillation of PROLENSA. The preservative in PROLENSA,
benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be
reinserted after 10 minutes following administration of PROLENSA.
ADVERSE REACTIONS
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared to
rates in the clinical trials of another drug and may not reflect the rates observed in
clinical practice.
The most commonly reported adverse reactions following use of PROLENSA
ophthalmic solution following cataract surgery include: anterior chamber
inflammation, foreign body sensation, eye pain, photophobia and vision blurred.
These reactions were reported in 3 to 8% of patients.
USE IN SPECIFIC POPULATIONS
Pregnancy
Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic exposure 90 times the
systemic exposure predicted from the recommended human ophthalmic dose [RHOD]
assuming the human systemic concentration is at the limit of quantification) and
rabbits at oral doses up to 7.5 mg/kg/day (150 times the predicted human systemic
exposure) produced no treatment-related malformations in reproduction studies.
However, embryo-fetal lethality and maternal toxicity were produced in rats and
rabbits at 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. In rats, bromfenac
treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted
human exposure), and caused dystocia, increased neonatal mortality, and reduced
postnatal growth at 0.9 mg/kg/day.
There are no adequate and well-controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response, this drug
should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the
fetal cardiovascular system (closure of ductus arteriosus), the use of PROLENSA
ophthalmic solution during late pregnancy should be avoided.
Nursing Mothers
Caution should be exercised when PROLENSA is administered to a nursing woman.
Pediatric Use
Safety and efficacy in pediatric patients below the age of 18 have not been
established.
Geriatric Use
There is no evidence that the efficacy or safety profiles for PROLENSA differ in
patients 70 years of age and older compared to younger adult patients.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up
to 0.6 mg/kg/day (systemic exposure 30 times the systemic exposure predicted from
the recommended human ophthalmic dose [RHOD] assuming the human systemic
concentration is at the limit of quantification) and 5 mg/kg/day (340 times the
predicted human systemic exposure), respectively, revealed no significant increases
in tumor incidence.
Bromfenac did not show mutagenic potential in various mutagenicity studies,
including the reverse mutation, chromosomal aberration, and micronucleus tests.
Bromfenac did not impair fertility when administered orally to male and female rats at
doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (systemic exposure 90
and 30 times the predicted human exposure, respectively).
PATIENT COUNSELING INFORMATION
Slowed or Delayed Healing
Advise patients of the possibility that slow or delayed healing may occur while using
NSAIDs.
Sterility of Dropper Tip
Advise patients to replace bottle cap after using and to not touch dropper tip to any
surface, as this may contaminate the contents. Advise patients that a single bottle of
PROLENSA be used to treat only one eye.
Concomitant Use of Contact Lenses
Advise patients to remove contact lenses prior to instillation of PROLENSA. The
preservative in PROLENSA, benzalkonium chloride, may be absorbed by soft contact
lenses. Lenses may be reinserted after 10 minutes following administration of
PROLENSA.
Concomitant Topical Ocular Therapy
If more than one topical ophthalmic medication is being used, the medicines should
be administered at least 5 minutes apart.
Rx Only
Manufactured by:
Bausch + Lomb, a division of Valeant Pharmaceuticals
North America LLC, Bridgewater, NJ 08807 USA
Product under license from:
Senju Pharmaceutical Co., Ltd., Osaka, Japan 541-0046
Prolensa is a trademark of Bausch & Lomb Incorporated or its affiliates.
© Bausch & Lomb Incorporated
Revised: 06/2016
Based on: 9306701/9306801
PRA.0119.USA.16
APRIL 1, 2017 :: Ophthalmology Times
17
surgery
FIGURE 9
CASES
( Continued from page 14 )
lowed by laser ASA surgery to bring the eye
to emmetropia.
(All images courtesy Arun C. Gulani, MD)
FIGURE 6 This patient has extensive ectasia
with abnormal vision despite Intacs surgery
performed by his LASIK surgeon. After the eye
was confirmed to be stable, laser ASA was performed to achieve a markedly improved visual
outcome from 20/400 preoperatively to 20/30
postoperatively, a result that to this patient
was nearly 100%.
FIGURE 7 Crosslinking also can be performed
before or after corneal manipulation with Intacs or Intacs combined with conductive keratoplasty or even after staged procedures such
as laser with an implantable collamer lens
(ICL) to make the visual end point stable and
permanent.
FIGURES 8 TO 10 The patient presented after
having undergone Intacs placement to treat
keratoconus followed by crosslinking, but the
FIGURE 10
vision remained extremely poor. Considering
that the patient had already undergone these
procedures, my principle is always to respect
the work of the previous surgeon, and therefore, I opted to perform laser ASA surgery
following a refractive evaluation in order to
achieve emmetropia. Figure 10 summarizes
the treatment that resulted in a happy patient
with 20/20 vision.
laser the cornea and correct the astigmatism
to reach emmetropia.
FIGURE 13 When corneas with keratoconus
are more unstable and they cannot be directionally improved,
they must be rebuilt using variArun C. Gulani,
ous lamellar techniques. In this
MD, explains how
patient, the resultant lamellar
he approaches each
keratoplasty results in normalcase of keratoconus
ization of the cornea.
TAKE-HOME
FIGURES 11 AND 12 There
are always cases in which surgeons should not maintain a
low threshold to perform surgical acrobatics. Refraction is
with the mindset that
the most important driving
the eye can possibly
force in the quest for emmereach the best visual
tropia. This patient showcases
outcome by using all
that concept. This patient was
available technologies
referred to me after breakage
and techniques,
of his Ferrara rings (Ferrara
performed singly or in
Ophthalmics); these rings had
staged combinations,
been implanted outside of the
to the patient’s best
US. The refractive examinaadvantage.
tion showed that, despite the
appearance of the rings, the
patient was still best corrected
to emmetropia. Because the previous sur- such as toric
geon had done an excellent job, I opted to
FIGURE 14 The lesson this figure emphasizes is that surgeons
should not become so enamored
by topography that their desire
for perfection is decreased. Although topography indicates the
patient has form fruste keratoconus, as long as stability and
accuracy of corneal measurement is confirmed, implantation of premium IOL implants,
IOLs, can be performed.
Continues on page 23 : Keratoconus
APRIL 1, 2017 :: Ophthalmology Times
23
surgery
FIGURE 11
FIGURE 12
FIGURE 15
FIGURE 16
FIGURE 13
Anterior lamellar Kplasty for lasik ecsasia
FIGURE 14
KERATOCONUS
( Continued from page 17 )
FIGURE 15. A similar scenario to that in the
previous case scenario is seen in this figure,
which documents that while the cornea is abnormal, lowering the surgical expectations is
unacceptable.
(All images courtesy Arun C. Gulani, MD)
FIGURE 16. This figure shows various presentations of patients who have keratoconus and
have undergone incisional surgeries to treat
the keratoconus and also might have associated cataracts.
CONCLUSION
All of these cases scenarios, which are an everyday occurrence in my practice, demonstrate my desire to take every patient to emmetropia despite the “so-called” complexity
of the cases.
This desire leads us to neutralize our mindset like that of a mathematician to solve the
problem beyond the published formulas that
are taught for addressing these scenarios in
most cases, of course, with patient safety
and their vision goals being the backbone
of these concepts. This allows us to develop
unique vision recipes for each patient and
bring them to uncorrected emmetropia.
I encourage you to understand each equation to help you create a unique formula for
each case. May I encourage you to “think outside the cone.” ■
ARUN C. GULANI, MD, is founding director and chief surgeon
of the Gulani Vision Institute, Jacksonville, FL. Dr. Gulani has no
financial interests to declare.
For this article in its entirely, including
images from more case scenarios,
go to OphthalmologyTimes.com/
TreatmentRecipe
APRIL 1, 2017 :: Ophthalmology Times
24
surgery
LASIK enhancements for premium
IOLs more accurate with less dry eye
Studies show procedure more accurate than PRK, not contributor to ocular surface disease
By Vanessa Caceres; Reviewed by Robert K. Maloney, MD
OPHTHALMOLOGISTS MUST be
prepared to perform corneal refractive surgery
enhancements after cataract surgery—and LASIK
is often the optimal choice, according to Robert K. Maloney, MD.
Although data from MarketScope indicate
only about 5.9% of patients require enhancements with laser refractive surgery after premium IOLs, Dr. Maloney believes that is enough
to push the envelope.
“A 6% failure rate is not a lot but it is enough
to discourage a surgeon pretty quickly,” said
Dr. Maloney, Maloney Vision Institute, Los Angeles. “A certain number of patients will need
refractive touch-ups for astigmatism, hyperopia, and myopia. Refractive surgery needs to
be in your corneal armamentarium.”
Surgeons’ options for premium IOL enhancement after cataract surgery include LASIK, PRK,
limbal relaxing incisions (LRIs), and IOL exchange. However, LASIK or PRK is the most
common.
Dr. Maloney cited research findings that
LASIK is more accurate than PRK.1,2 In one
such study led by Manche et al.,1 68 eyes in
34 patients had one eye that had PRK and the
second eye that had LASIK.
“The standard deviation of LASIK was less
than PRK,” he said. “That’s the best measure
of accuracy as it tells you how
spread out the data is.”
LASIK enhancement
after cataract surgery
vs
LASIK enhancement
after LASIK
After cataract surgery
After LASIK
> Need to create flap, which
causes some unpredictable
refractive effect.
> Will cause some degree
of dry eye.
> Refractive effect of flap
creation is over.
> Dry eye has already happened.
It won’t get worse.
vs
You should be quicker to use methods other than LASIK to correct
residual refractive error after cataract surgery
> Consider LRI for residual astigmatism, if the spherical equivalent is within
0.25 D of plano.
> Consider IOL exchange or piggyback IOL for larger corrections or patients
with ocular surface disease.
(Source: Robert K. Maloney, MD)
dry eye among patients randomized to PRK
and LASIK.3,4
Another study examined the incidence of
dry eye in pseudophakic patients and found
no difference between the two surgical approaches.4 In Dr. Maloney and colleagues’
analysis of more than 700 patients, there was no difference
in dry eye occurrence, but PRK
Surgeons should
OT HER UNPUBLISHED
tended to cause more recurrent
consider LASIK over
RESEARCH
erosions.5
PRK
for
enhancement
In Dr. Maloney’s own unpubThe studies indicate that
after cataract surgery
lished research, the standard
LASIK enhancement after catwith premium IOLs,
deviation was also less for LASIK
aract surgery seems to be as good
noted one physician.
than PRK. In fact, the difference
as LASIK in virgin eyes, Dr. Mabetween the two types of surloney said. The one area where
gery was consistent even among
it may cause more problems is
lower corrections.
if the patient has had previous LASIK. How“With low corrections, which they typically ever, this is not a surprising finding, he added.
are after cataract surgery, LASIK is even betSurgeons should also consider other refracter,” he said.
tive options, such as LRIs for residual astigOcular surface disease is another surgeon matism if the spherical equivalent is within
concern after LASIK in cataract surgery pa- 0.25 D of plano, or IOL exchange or piggyback
tients who tend to be older. Again, Dr. Malo- IOL for larger corrections or for patients with
ney cited research that found no difference in ocular surface disease. ■
TAKE-HOME
References
1. Manche EE, Haw WW. Wavefront-guided laser in
situ keratomileusis (LASIK) versus wavefront-guided
photorefractive keratectomy (PRK): a prospective
randomized eye-to-eye comparison. Trans Am
Ophthalmol Soc. 2011;109:201-220.
2. Shortt AJ, Allan BD, Evans JR. Laser-assisted insitu keratomileusis (LASIK) versus photorefractive
keratectomy (PRK) for myopia. Cochrane Database
Syst Rev. 2013 Jan 31;1:CD005135.
3. Murakami Y, Manche EE. Prospective, randomized
comparison of self-reported postoperative dry eye
and visual fluctuation in LASIK and photorefractive
keratectomy. Ophthalmology. 2012;119:2220-2224.
4. Schallhorn SC, Venter JA, Teenan D, et al. Outcomes
of excimer laser enhancements in pseudophakic
patients with multifocal intraocular lens. Clin
Ophthalmol. 2016;10:765-776. 5. Hovanesian JA, Shah SS, Maloney RK. Symptoms
of dry eye and recurrent erosion syndrome after
refractive surgery. J Cataract Refract Surg.
2001;27:577-584.
ROBERT K. MALONEY, MD
E: [email protected]
This article was adapted from Dr. Maloney’s presentation at the 2016 meeting
of the American Society of Cataract and Refractive Surgery. He is a consultant
for Calhoun Vision, Johnson & Johnson Vision, and Presbia.
DON’T SETTLE FOR LESS THAN
THE COMPLETE EXPERIENCE.
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The advanced LenSx Laser delivers the complete cataract refractive experience.
Part of The Cataract Refractive Suite by Alcon, the LenSx® Laser performs across
the entire anterior segment, not just a part of it.
• Precise primary and secondary corneal incisions, and
arcuate incisions.
• Complete, reproducible capsulotomies with pristine edges.1
• Versatile fragmentation patterns to fit your surgical technique.
• Built on a proven fully upgradeable platform designed for both today’s
achievements and tomorrow’s advancements.
Visit LenSxLasers.com or talk to your
Alcon representative about the LenSx® Laser.
© 2016 Novartis 9/16 US-LSX-16-E-3831
1. Bala C, Xia Y, Meades K Electron microscopy of laser capsulotomy edge: Interplatform comparison.
Journal of Cataract & Refractive Surgery, Vol. 40, Issue 8, p1382–1389
LenSx® Laser Important Product Information for Cataract
Treatment
Caution
Federal Law restricts this device to sale and use by or on the order
of a physician or licensed eye care practitioner.
Indication
The LenSx® Laser is indicated for use in patients undergoing
cataract surgery for removal of the crystalline lens. Intended uses
in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/
incisions in the cornea, each of which may be performed either
individually or consecutively during the same procedure.
Restrictions
@ Patients must be able to lie flat and motionless in a supine
position.
@ Patient must be able to understand and give an informed
consent.
@ Patients must be able to tolerate local or topical anesthesia.
@ Patients with elevated IOP should use topical steroids only
under close
medical supervision.
Contraindications
@ Corneal disease that precludes applanation of the cornea or
transmission of laser light at 1030 nm wavelength
@ Descemetocele with impending corneal rupture
@ Presence of blood or other material in the anterior chamber
@ Poorly dilating pupil, such that the iris is not peripheral to
the intended diameter for the capsulotomy
@ Conditions which would cause inadequate clearance
between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only)
@ Previous corneal incisions that might provide a potential
space into which the gas produced by the procedure can
escape
@ Corneal thickness requirements that are beyond the range of
the system
@ Corneal opacity that would interfere with the laser beam
@ Hypotony or the presence of a corneal implant
@ Residual, recurrent, active ocular or eyelid disease, including
any corneal abnormality (for example, recurrent corneal
erosion, severe basement membrane disease)
@ History of lens or zonular instability
@ Any contraindication to cataract or keratoplasty
@ This device is not intended for use in pediatric surgery.
Warnings
The LenSx® Laser System should only be operated by a physician
trained in its use.
The LenSx® Laser delivery system employs one sterile disposable
Patient Interface consisting of an applanation lens and suction
ring. The Patient Interface is intended for single use only. The
disposables used in conjunction with ALCON® instrument products
constitute a complete surgical system. Use of disposables other
than those manufactured by Alcon may affect system performance
and create potential hazards.
The physician should base patient selection criteria on professional
experience, published literature, and educational courses. Adult
patients should be scheduled to undergo cataract extraction.
Precautions
@ Do not use cell phones or pagers of any kind in the same
room as the
LenSx® Laser.
@ Discard used Patient Interfaces as medical waste.
Complications
@ Capsulotomy, phacofragmentation, or cut or incision
decentration
@ Incomplete or interrupted capsulotomy, fragmentation, or
corneal
incision procedure
@ Capsular tear
@ Corneal abrasion or defect
@ Pain
@ Infection
@ Bleeding
@ Damage to intraocular structures
@ Anterior chamber fluid leakage, anterior chamber collapse
@ Elevated pressure to the eye
Attention
Refer to the LenSx® Laser Operator’s Manual for a complete listing
of indications, warnings and precautions.
© 2016 Novartis 9/16 US-LSX-16-E-3831
APRIL 1, 2017 :: Ophthalmology Times
surgery
When expanding a pupil,
know your device options
Small study: Pupil expanders provide similar defect risks
By Fred Gebhart; Reviewed by Brian Hunter, MD
HUMANS ARE CREATURES of habit,
of risks: iris sphincter tears, hemorrhage, zonular
even ophthalmologists. Having learned to use dialysis, anterior or posterior capsular damage,
one device for pupil expansion, it is easy to for- increased operating time, and lens dislocation
get that there are alternative devices.
or drop. Postoperative risks include uveitis, ir“I have seen too many residents having a hard regular pupil, transillumination defects (TIDs),
time getting the most familiar device [Malyu- iris atrophy, and corneal edema.
gin Ring, MicroSurgical Technology] into the
“We need pupil expansion devices to provide
iris, just shredding the mar- adequate exposure, to maximize safety and efgins, and an even harder time ficiency, maximize postoperative results, and
getting it out again,” said Brian prevent complications,” Dr. Hunter said. “You
A. Hunter, MD, Fishkind, Bake- don’t want to make the problem worse by causwall, Maltman, Hunter and As- ing damage with your device.”
sociates Eye Care and Surgery
Iris hooks are the simplest pupil expansion
Center, and clinical professor devices and are useful when the patient has
Dr. Hunter
of ophthalmology, University asymmetric iris defects. However, hooks are difof Arizona, Tucson.
ficult to position properly, increase operating
“The Malyugin Ring is an effective device, time, and can cause pupil damage.
but it has a steep learning curve,” Dr. Hunter
The Malyugin Ring is easy to insert and gives
added. “I looked around and found the I-Ring a good field of view, but the device has a steep
(Beaver-Visitec International),
learning curve with complex rewhich appeared to be a lot easmoval, especially for less-expeier for residents to get into the
rienced surgeons.
eye and out again without causIt also is prone to iris TIDs,
When it concerns
ing excessive damage.”
sphincter
and anterior chamber
pupil expansion
Dr. Hunter outlined his experitears,
and
requires
special instrudevices, a single
ence with the I-Ring. He pointed
mentation.
It
also
has
the advandevice is not perfect
out optical outcomes with the
tage
of
being
the
most
familiar
for every surgeon
new device are similar to those
device
on
the
market
and the
and patient. By
obtained with the Malyugin Ring,
de-facto
choice
for
experienced
being familiar with
but few resident training programs
ophthalmologists.
multiple devices
appear to offer an option.
The I-Ring is easy to insert and
early in training,
Most programs introduce the
to
remove
and has a smaller field
residents will have
Malyugin Ring as the first and
of
view
than
the Malyugin Ring
more devices in their
only pupil expansion device, Dr.
—6.3
mm
compared
with between
armamentarium to
Hunter said. The familiar device
6.25
to
7.0
mm.
The
I-Ring also
provide the best
is not necessarily better. Havis
subject
to
TIDs
and
the flexpatient outcomes.
ing mastered one steep learning
ibility that makes it easy to incurve, many ophthalmologists are
sert and remove also makes it
wary of learning a new device.
difficult use properly.
The problem is most acute in patients with
small pupils with intraoperative floppy iris synSM A L L ST U DY
drome (IFIS). These patients do not respond Dr. Hunter initially thought he was seeing more
adequately to pharmacological mydriasis and TIDs from the I-Ring than from the Malyugin
need mechanical dilation.
Ring. The I-Ring has a slightly larger profile on
the pupil, so it seems reasonable that it could
RISKS WITH NO DEVICE
cause more defects.
Not using some sort of device to achieve adeNone of the defects he noted were visually
quate intraoperative mydriasis carries a long list significant, but they were large enough to be
TAKE-HOME
APRIL 1, 2017 :: Ophthalmology Times
27
surgery
visible during an exam, even if patients did not see any effect.
“I decided to do a small study with
my own patients, looking to see just
what kind of iris defects they had from
the two devices,” Dr. Hunter said. “At
least in my practice, results between
the Malyugin Ring and the I-Ring were
very similar and were not as significant as I thought I was seeing.”
DIVING DEEPER
Dr. Hunter followed 14 patients, 7
with the I-Ring and 7 with the Malyugin Ring.
Outcomes were inflammation, TIDs,
and pupil shape 1-day postoperatively
and 14-days postoperatively.
Patient demographics were similar
in the two groups, as were the preoperative pupil size and cataract grade.
Postoperative results were similar.
On day 1, the I-Ring had a mean of 1.5
cells compared with 1.3 cells for the
Malyugin Ring. Both rings had a single TID. The I-Ring had 2 pupil defects
and the Malyugin has zero defects.
On day 14, the I-Ring had no cells
compared with 0.1 cells for the Malyugin Ring. The I-Ring had 1 TID and
the Malyugin Ring had 2. Neither ring
showed any pupil defects.
“The I-Ring works well, though no
one device is right for every surgeon
or patient,” Dr. Hunter said. “I would
encourage more people to use the I-
A retrospective review of pupil expansion devices in intraoperative floppy iris
syndrome during cataract surgery was conducted by an experienced surgeon
in an ambulatory surgery center. Such devices were able to produce mydriasis
without significant transillumination defects. (Photos courtesy of Brian A. Hunter, MD)
Ring, especially those [physicians] who are in training.
You get better outcomes without the steep Malyugin Ring
learning curve. The I-Ring is
a much better way of getting
[residents] to do those harder
cases earlier.” ■
BRIAN A. HUNTER, MD
P: 520/293-6740
E: [email protected]
This article was adapted from Dr. Hunter's presentation
at the 2016 American Society for Cataract and Refractive Surgery annual meeting. He does not have any
financial interest pertaining to the subject matter.
28
INNOVATIONS IN
Special Report )
FEMTOSECOND LASER TECHNOLOGY
ADVANCES CONTINUE TO PROGRESS FOR FEMTOSECOND LASER-ASSISTED CATARACT SURGERY
Uncorrected Distance VA
100
80
70
60
Uncorrected Intermediate VA
FLACS
Manual
90
80
FLACS
Manual
70
50
60
40
50
30
40
30
20
20
10
10
0
0
20/20
20/30
20/40
20/16
20/20
20/25
Patients in femtosecond
laser and manual
cataract surgery groups
both had excellent
distance, intermediate,
and near vision, but the
FLACS group had better
accuracy to refractive
target. (Figure courtesy
of Jeffrey Whitman, MD)
STUDY: VISUAL ACUITY
OUTCOMES SIMILAR,
BUT FLACS HAS SOME
ADVANTAGES
Better refractive prediction with FLACS than manual surgery
By Vanessa Caceres; Reviewed by Jeffrey Whitman, MD
take-home
An ongoing study of
100 patients receiving
femtosecond laser
or manual cataract
surgery found
potential advantages
for FLACS, including
better refractive
predictability.
F
emtosecond laser-assisted cataract surgery (FLACS) facilitated
a precise capsulotomy and reduced phaco energy in a recent
ongoing study with about 100
consecutive eyes, said Jeffrey
Whitman, MD, Key-Whitman Eye Center, Dallas.
The study focuses on tracking the benefits of FLACS over manual cataract surgery in relation to visual acuity and refractive predictability in eyes receiving an accommodating IOL (Crystalens
or Trulign, Bausch + Lomb).
The eyes in the prospective study were randomly divided to
receive FLACS or manual surgery; in the FLACS arm, a femtosecond laser (Victus, Bausch + Lomb) was used for primary corneal
incision, capsulotomy, and lens fragmentation. The same surgeon
performed all cases, Dr. Whitman said.
At 90 days after surgery, distance, intermediate, and near visual
acuity were measured. Postoperatively, the mean uncorrected distance visual acuity was nearly identical—20/30 in the laser group
and 20/31 in the manual group.
In the laser group, 28% were 20/20 or better, compared with
30% in the manual group. In the FLACS group, 70% of patients
were 20/30 or better compared with 64% in the manual group,
and 80% were 20/40 or better, compared with
76% in the manual group.
The mean uncorrected intermediate visual
acuity was nearly the same—20/17 and 20/18
in the laser and manual surgery groups, respectively. Ninety-eight percent were 20/25
or better in the laser group compared with
92% in the manual group, Dr. Whitman said.
For uncorrected near visual acuity, the mean
was also almost identical—20/28 and 20/27 in
the FLACS and manual groups, respectively.
Twenty-eight percent versus 24% of patients
were 20/20 or better in the FLACS versus manual groups, respectively. Seventy-four percent
versus 84% were 20/30 or better; and 90%
versus 92% were 20/40 or better, respectively.
Distance-corrected near visual acuity was
20/36 in the FLACS group compared with 20/37
in the manual group. Sixteen percent of eyes
were 20/20 or better in the FLACS group compared with 10% in the manual group, and 48%
were 20/30 or better versus 50%, respectively.
Seventy percent of patients in the FLACS group
were 20/40 or better compared with 76% in
the manual surgery group.
The laser group had a higher percentage of
patients with accuracy to refractive target, Dr.
Whitman said, in which 80% were within 0.5
D compared with 72% in the manual group,
and 92% in the laser group were within 0.75
D compared with 86% in the manual group.
Although both groups had excellent results,
FLACS had an edge. “FLACS provides potential advantages over manual technique due to
more precise capsulotomy and reduced phaco
energy,” Dr. Whitman concluded. ■
JEFFREY WHITMAN, MD
E: [email protected]
This article was adapted from Dr. Whitman’s presentation at the 2016 meeting
of the American Society of Cataract and Refractive Surgery. He is a consultant and
conducts research for Bausch + Lomb.
THE POWER OF PREEMPTION
OMIDRIA® is the first and only
FDA-approved drug that provides
continuous intracameral delivery
of NSAID and mydriatic/anti-miotic
therapy during cataract surgery1
LEARN MORE AT
ASCRS BOOTH #1915
CHOOSE OMIDRIA FOR YOUR NEXT CATARACT SURGERY PATIENT
• Preempt miosis and inhibit
postoperative pain1
• Block the surgically induced
inflammatory cascade with the
first and only NSAID FDA-approved
for intracameral use1
• Eliminate the risks and liabilities
of compounded products
by using FDA-approved,
GMP-manufactured OMIDRIA
• Avoid reimbursement difficulties
by using broadly covered OMIDRIA
and the OMIDRIAssure® services
(OMIDRIAssure.com)*
IMPORTANT SAFETY INFORMATION
OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% must be added to irrigation
solution prior to intraocular use.
OMIDRIA is contraindicated in patients with a known hypersensitivity to any of its ingredients.
Systemic exposure of phenylephrine may cause elevations in blood pressure.
Use OMIDRIA with caution in individuals who have previously exhibited sensitivities to
acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory drugs
(NSAIDs), or have a past medical history of asthma.
The most commonly reported adverse reactions at 2-24% are eye irritation, posterior
capsule opacification, increased intraocular pressure, and anterior chamber inflammation.
Use of OMIDRIA in children has not been established.
INDICATIONS AND USAGE
OMIDRIA is added to ophthalmic irrigation solution used during cataract surgery or intraocular
lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis
and reducing postoperative ocular pain.
Reference: 1. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2016.
Please see the Full Prescribing Information at
www.omidria.com/prescribinginformation.
*Individual insurance coverage and policies may vary, and Omeros does not guarantee
insurance coverage or payment. Omeros offers payments under the OMIDRIAssure
“We Pay the Difference” program on behalf of qualifying patients. OMIDRIAssure
is subject to change without notice.
Visit www.omidria.com
OMEROS®, the OMEROS logo®, OMIDRIA®, the OMIDRIA logo®, and
OMIDRIAssure® are registered trademarks of Omeros Corporation.
© Omeros Corporation 2017, all rights reserved. 2017-007
APRIL 1, 2017 :: Ophthalmology Times
30
Special Report )
INNOVATIONS IN
FEMTOSECOND LASER TECHNOLOGY
FLACS cost, benefit outweigh manual?
Yes. Use of FLACS is supported by
consideration of benefits, costs
( Continued from page 1 )
“There is no evidence that the refractive result is worse after FLACS, while there is evidence that FLACS creates a more precise capsulotomy, reduces ultrasound energy usage,
postoperative corneal edema, and corneal endothelial cell loss,” Dr. Cionni said.
“Furthermore, FLACS does not increase the
overall incidence of complications, it may be associated with a lower rate of vitreous loss, and
it is immensely helpful in challenging cases,
including eyes with posterior polar, brunescent or white tumescent cataract, as well as
those with zonulopathy, where it can allow
safe capsulotomy and reduce the need for ultrasound energy,” he added.
SPEAKING FROM
EXPERIENCE
As a proponent for FLACS, Dr. Cionni speaks
based on substantial experience. In February
2011, the first commercially available femtosecond laser installation occurred at The Eye
Institute of Utah, and as of October 2016, Dr.
Cionni had performed more than 2,600 FLACS
plants and may vary by 0.17D from the labeled
value. However, the fact that true effective
lens position (ELP) remains unknown is the
bigger issue.
“Even using FLACS and with intraoperative aberrometry, the noise that is introduced
into the IOL calculation by estimating ELP
is simply too great to demonstrate superiority of one technique versus another,” said Dr.
Cionni, adding that the A constant for FLACS
cases will differ and also needs to be optimized
when investigators are comparing refractive
outcomes of the two techniques.
R EFR ACTI V E BENEFITS
OF FL ACS
Suggesting that a contralateral eye-controlled
design is best suited for comparing FLACS and
manual cataract surgery because it eliminates
confounding from estimating ELP, Dr. Cionni
cited the results of one study that found better
outcomes with FLACS [Conrad-Hengerer I, et al.
J Cataract Refract Surg. 2015;41:1356-1364].
In that study including 100 patients, the refractive outcome was within 0.5 D of target in
92% of FLACS eyes but in only 71% of conventional cases.
‘The precision of the laser-created arcuate incisions
in terms of depth and position is better than what
can be achieved manually.’ — Robert J. Cionni, MD
procedures, counting only routine and premium
cases but not more difficult, complex cases.
“FLACS now represents 35% of all of my cataract cases, and data from Market Scope and
Alcon Laboratories show it has been growing
worldwide,” he said.
F L AW E D R E S E A R C H
Discussing the discrepancy in the findings of
comparative studies investigating refractive
outcomes of FLACS and conventional cataract
surgery, Dr. Cionni pointed out that the result
is only as good as the weakest link, and there
are two weak points that persist.
The first has to do with IOL power, which
is available in steps of just 0.5 D for most im-
In addition, FLACS was associated with earlier refractive stability compared with manual
cataract surgery (1 week versus 1 month).
Dr. Cionni also reviewed evidence to support the idea that FLACS has advantages for
achieving more predictable results when correcting astigmatism, using either an incisional
technique or a toric IOL.
The difference reflects the increased precision of the laser versus a manual technique
for creating arcuate incisions and the capsulotomy, Dr. Cionni said.
“The precision of the laser-created arcuate
incisions in terms of depth and position is better than what can be achieved manually,” Dr.
Cionni said. “In addition, numerous studies
TRAUMATIC CATARACT
VIDEO Traumatic cataract in young
patient. Anterior capsular plaque and large zonular
dialysis makes manual capsulotomy impossible
but accomplished easily with femtosecond laser.
The capsulotomy can be centered on the lens
center with femtosecond laser. The edge is strong
to allow for modified CTR (Cionni ring) placement
and suturing to the scleral wall.
(Video courtesy of Robert J. Cionni, MD)
Go to OphthalmologyTimes.com/FLACSBenefits
show that even overlap of the capsulotomy
rim over the IOL optic should result in less tilt
for a toric IOL, and the benefit of less tilt will
be particularly important when implanting a
higher-power toric IOL.
“As we recently reported in a published paper
[Woodcock MG, et al. J Cataract Refract Surg.
2016;42:817-825], 90% of eyes undergoing toric
IOL implantation had less than 0.5 D of residual astigmatism when the procedure combined FLACS with intraoperative aberrometry
and other best methods for choosing toric IOL
magnitude and alignment,” he said.
COST AND TIME ISSUES
Addressing economic issues, Dr. Cionni said
that the cost of FLACS is fully supported by
self-pay. Many patients have the means and
willingness to pay for a FLACS procedure. The
fees they pay out of pocket support the extra
cost of the laser that is incurred by the surgery
center and that compensates for the extra time
spent by surgeons when they perform FLACS. ■
ROBERT J. CIONNI, MD
E: [email protected]
This article was adapted from Dr. Cionni’s presentation at the 2016 meeting of the
American Academy of Ophthalmology. Dr. Cionni is a consultant to Alcon Laboratories
and Johnson & Johnson Vision.
APRIL 1, 2017 :: Ophthalmology Times
31
Special Report )
INNOVATIONS IN
FEMTOSECOND LASER TECHNOLOGY
FLACS cost, benefit outweigh manual?
No. Increased cost, other limitations
overshadow potential benefits of FLACS
( Continued from page 1 )
urge surgeons who are considering the purchase of a femtosecond laser to perform a financial analysis for their center.”
CLINICAL CHALLENGES
Dr. Braga-Mele first cited a learning curve so
that surgeons can initially expect to spend an
additional 5 to 7 minutes on each case.
cific surgical techniques. Dr. Braga-Mele recommended pulling the laser-created capsulotomy
centrally to minimize the potential for radial tears.
To avoid posterior capsule rupture during
hydrodissection, particularly in eyes with a
posterior polar cataract, she advocated performing gentle decompression of the intralenticular air bubbles created by the laser treatment.
In addition, surgeons should be prepared
for cortex removal to be more challenging.
“The edge that is present after manual capsulorhexis is lacking when the
femtosecond laser is used for
capsulotomy,” she said. “Surgeons may have to re-learn
how to do a tangential sweep
and may find it necessary to go
a little farther underneath the
capsule rim than they might
feel comfortable doing.”
The release of prostaglandins with FLACS has also been
associated with increased indices of inflammation, including a trend toward more cystoid macular edema.
In addition, FLACS may worsen dry eye.
“These issues require further study, but they
are something to consider when using FLACS, especially in premium cases,” Dr. Braga-Mele said.
Large studies comparing FLACS with conventional surgery failed to find that FLACS
was superior. Data from a case-control study
‘I would urge surgeons who are
considering the purchase of a
femtosecond laser to perform a
financial analysis for their center.’
— Rosa Braga-Mele, MD
The extra time needed should be considered with the effects FLACS has on workflow.
“Surgeons need to think through logistical
hitches to avoid bottlenecks,” she said. “Consideration has to be given to where the laser will
be installed, including the potential need for a
separate room. Scheduling will need to take into
account how many surgeons will be using the
laser and how many procedures will be booked.”
Surgeons also need to be aware that femtosecond laser treatment induces prostaglandin
release that may cause pupillary constriction.
They should be prepared to manage miosis by
having a pharmacological adjunct on hand.
Awareness of other potential complications
associated with FLACS supports the use of spe-
ROSA BRAGA-MELE, MD
E: [email protected]
This article was adapted from Dr. Braga-Mele’s presentation at the 2016 meeting of
the American Academy of Ophthalmology. Dr. Braga-Mele is a consultant to companies
that market femtosecond lasers for cataract surgery.
WHAT DO YOU THINK? Weigh in on the femtosecond laser-assisted cataract surgery
(FLACS) debate. Who presented the better argument?
.COM
Go online to vote at OphthalmologyTimes.com/FLACSPoll
FDA approves update to ZEISS laser for SMILE
CARL ZEISS MEDITEC announced it
has received FDA approval of a software update
to its femtosecond laser system (VisuMax) for
the small-incision lenticule extraction (ReLEx
SMILE) procedure.
With this approval, surgeons can now per-
conducted by the European Society of Cataract
and Refractive Surgeons showed FLACS was
safe but did not outperform manual surgery.
A meta-analysis including data from 14,567
eyes determined there were no statistically significant differences between FLACS and conventional
surgery with respect to patient-important visual
and refractive outcomes and complications [Popovic M et al. Ophthalmology. 2016;123:2113-2126].
The review identified statistically significant
differences favoring FLACS in analyses of effective phacoemulsification time, capsulotomy circularity, postoperative central corneal thickness,
and corneal endothelial cell reduction.
However, FLACS was associated with higher
prostaglandin concentrations and higher rates
of posterior capsular tears. Dr. Braga-Mele said
despite its limitations, FLACS is here to stay,
and offered some ideas to make it better.
“We need to lower the cost to ourselves and
our patients,” she said. “We need platforms with
a smaller footprint that will fit in the operating room and make FLACS more convenient
for the patient and the surgeon.” ■
form SMILE for the correction of myopia in
the United States.
The minimally invasive corneal refractive
procedure is indicated for use in the reduction or elimination of myopia –1 to –8 D, with
≤ –0.50 D cylinder and MRSE –8.25 D in the
eye to be treated in patients who are 22 years
of age or older with documentation of stable
manifest refraction over the past year.
With more than 700,000 procedures performed internationally since its introduction
in 2011, and offered in about 600 clinics in 62
countries around the world, the laser vision
correction procedure has demonstrated safety
and effectiveness, according to a press release. ■
Indications and Usage
BromSite™ (bromfenac ophthalmic solution) 0.075% is a
nonsteroidal anti-inflammatory drug (NSAID) indicated for
the treatment of postoperative inflammation and prevention
of ocular pain in patients undergoing cataract surgery.
Important Safety Information
• Slow or Delayed Healing: All topical nonsteroidal
anti-inflammatory drugs (NSAIDs), including BromSite
(bromfenac ophthalmic solution) 0.075%, may slow
or delay healing. Topical corticosteroids are also known
to slow or delay healing. Concomitant use of topical
NSAIDs and topical steroids may increase the potential
for healing problems.
• Potential for Cross-Sensitivity: There is the potential
for cross-sensitivity to acetylsalicylic acid, phenylacetic
acid derivatives, and other NSAIDs, including BromSite
(bromfenac ophthalmic solution) 0.075%. Therefore,
caution should be used when treating individuals who
have previously exhibited sensitivities to these drugs.
• Increased Bleeding Time of Ocular Tissue:
With some NSAIDs, including BromSite (bromfenac
ophthalmic solution) 0.075%, there exists the potential
for increased bleeding time due to interference with
platelet aggregation. There have been reports that
ocularly applied NSAIDs may cause increased bleeding
of ocular tissues (including hyphemas) in conjunction
with ocular surgery.
It is recommended that BromSite be used with caution
in patients with known bleeding tendencies or who
are receiving other medications which may prolong
bleeding time.
• Use of topical NSAIDs may result in keratitis. Patients
with evidence of corneal epithelial breakdown should
immediately discontinue use of topical NSAIDs, including
BromSite (bromfenac ophthalmic solution) 0.075%, and
should be closely monitored for corneal health. Patients
with complicated ocular surgeries, corneal denervation,
corneal epithelial defects, diabetes mellitus, ocular
A DROP OF PREVENTION
FOR YOUR CATARACT SURGERY PATIENTS
Introducing the FIRST and ONLY NSAID indicated
to prevent ocular pain in cataract surgery patients1
Defend against pain and combat postoperative inflammation with
the penetrating power of BromSite™ formulated with DuraSite®1
• DuraSite increases retention time on the ocular surface and absorption of bromfenac2-5
– Allows for increased aqueous humor concentrations
• Ensures complete coverage throughout the day with BID dosing1
Visit bromsite.com to find out more.
Formulated with
surface diseases (e.g., dry eye syndrome), rheumatoid
arthritis, or repeat ocular surgeries within a short period
of time may be at increased risk for corneal adverse events
which may become sight threatening. Topical NSAIDs
should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests
that use more than 24 hours prior to surgery or use
beyond 14 days postsurgery may increase patient risk for
the occurrence and severity of corneal adverse events.
• BromSite should not be administered while wearing
contact lenses. The preservative in BromSite, benzalkonium
chloride, may be absorbed by soft contact lenses.
DELIVERY SYSTEM
• The most commonly reported adverse reactions
in 1% to 8% of patients were anterior chamber
inflammation, headache, vitreous floaters, iritis,
eye pain, and ocular hypertension.
You are encouraged to report negative side
effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see brief summary of full Prescribing
Information on the adjacent page.
NSAID=nonsteroidal anti-inflammatory drug.
References: 1. BromSite [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2016. 2. Hosseini K, Hutcheson J, Bowman L. Aqueous humor concentration of
bromfenac 0.09% (Bromday™) compared with bromfenac in DuraSite® 0.075% (BromSite™) in cataract patients undergoing phacoemulsification after 3 days dosing. Poster
presented at: ARVO Annual Meeting; May 5-9, 2013; Seattle, Washington. 3. Bowman LM, Si E, Pang J, et al. Development of a topical polymeric mucoadhesive ocular delivery
system for azithromycin. J Ocul Pharmacol Ther. 2009;25(2):133-139. 4. ClinicalTrials.gov. Aqueous humor concentration of InSite Vision (ISV) 303 (bromfenac in DuraSite) to
Bromday once daily (QD) prior to cataract surgery. https://clinicaltrials.gov/ct2/show/results/NCT01387464?sect=X70156&term=insite+vision&rank=1. Accessed July 18, 2016.
5. Si EC, Bowman LM, Hosseini K. Pharmacokinetic comparisons of bromfenac in DuraSite and Xibrom. J Ocul Pharmacol Ther. 2011;27(1):61-66.
Sun Ophthalmics is a division of Sun Pharmaceutical Industries, Inc.
© 2016 Sun Pharmaceutical Industries, Inc. All rights reserved.
DuraSite® and BromSite™ are trademarks of Sun Pharma Global FZE.
SUN-OPH-BRO-142 09/2016
BromSite™ (bromfenac ophthalmic solution) 0.075%
Brief Summary
INDICATIONS AND USAGE
BromSite™ (bromfenac ophthalmic solution) 0.075% is a nonsteroidal
anti-inflammatory drug (NSAID) indicated for the treatment of postoperative
inflammation and prevention of ocular pain in patients undergoing cataract surgery.
DOSAGE AND ADMINISTRATION
Recommended Dosing
One drop of BromSite should be applied to the affected eye twice daily (morning
and evening) 1 day prior to surgery, the day of surgery, and 14 days postsurgery.
Use with Other Topical Ophthalmic Medications
BromSite should be administered at least 5 minutes after instillation
of other topical medications.
Dosage Forms and Strengths
Topical ophthalmic solution: bromfenac 0.075%.
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Slow or Delayed Healing
All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite
(bromfenac ophthalmic solution) 0.075%, may slow or delay healing. Topical
corticosteroids are also known to slow or delay healing. Concomitant use of topical
NSAIDs and topical steroids may increase the potential for healing problems.
USE IN SPECIFIC POPULATIONS
Pregnancy
Risk Summary
There are no adequate and well-controlled studies in pregnant women to inform any
drug associated risks. Treatment of pregnant rats and rabbits with oral bromfenac did
not produce teratogenic effects at clinically relevant doses.
Clinical Considerations
Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the
fetal cardiovascular system (closure of ductus arteriosus), the use of BromSite during
late pregnancy should be avoided.
Data
Animal Data
Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a
unilateral daily human ophthalmic dose on a mg/m2 basis, assuming 100% absorbed)
and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose
on a mg/m2 basis) produced no structural teratogenicity in reproduction studies.
However, embryo-fetal lethality, neonatal mortality and reduced postnatal growth
were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced
in rabbits at 7.5 mg/kg/day. Because animal reproduction studies are not always
predictive of human response, this drug should be used during pregnancy only if
the potential benefit justifies the potential risk to the fetus.
Lactation
There are no data on the presence of bromfenac in human milk, the effects on the
breastfed infant, or the effects on milk production; however, systemic exposure to
bromfenac from ocular administration is low. The developmental and health benefits
of breastfeeding should be considered along with the mother’s clinical need for
bromfenac and any potential adverse effects on the breast-fed child from bromfenac
or from the underlying maternal condition.
Potential for Cross-Sensitivity
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid
derivatives, and other NSAIDs, including BromSite (bromfenac ophthalmic solution)
0.075%. Therefore, caution should be used when treating individuals who have
previously exhibited sensitivities to these drugs.
Pediatric Use
Safety and efficacy in pediatric patients below the age of 18 years
have not been established.
Increased Bleeding Time of Ocular Tissue
With some NSAIDs, including BromSite (bromfenac ophthalmic solution) 0.075%,
there exists the potential for increased bleeding time due to interference with
platelet aggregation. There have been reports that ocularly applied NSAIDs may
cause increased bleeding of ocular tissues (including hyphemas) in conjunction
with ocular surgery.
NONCLINICAL TOXICOLOGY
It is recommended that BromSite be used with caution in patients with known
bleeding tendencies or who are receiving other medications which may prolong
bleeding time.
Keratitis and Corneal Reactions
Use of topical NSAIDs may result in keratitis. In some susceptible patients,
continued use of topical NSAIDs may result in epithelial breakdown, corneal
thinning, corneal erosion, corneal ulceration or corneal perforation. These events
may be sight threatening. Patients with evidence of corneal epithelial breakdown
should immediately discontinue use of topical NSAIDs, including BromSite (bromfenac
ophthalmic solution) 0.075%, and should be closely monitored for corneal health.
Post-marketing experience with topical NSAIDs suggests that patients with
complicated ocular surgeries, corneal denervation, corneal epithelial defects,
diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid
arthritis, or repeat ocular surgeries within a short period of time may be at increased
risk for corneal adverse events which may become sight threatening. Topical NSAIDs
should be used with caution in these patients.
Geriatric Use
There is no evidence that the efficacy or safety profiles for BromSite differ
in patients 65 years of age and older compared to younger adult patients.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up
to 0.6 mg/kg/day (129 times a unilateral daily dose assuming 100% absorbed, on a
mg/m2 basis) and 5 mg/kg/day (540 times a unilateral daily dose on a mg/m2 basis),
respectively revealed no significant increases in tumor incidence.
Bromfenac did not show mutagenic potential in various mutagenicity studies, including
the bacterial reverse mutation, chromosomal aberration, and micronucleus tests.
Bromfenac did not impair fertility when administered orally to male and female rats
at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (195 and 65 times a
unilateral daily dose, respectively, on a mg/m2 basis).
PATIENT COUNSELING INFORMATION
Slow or Delayed Healing
Advise patients of the possibility that slow or delayed healing may occur
while using NSAIDs.
Concomitant Topical Ocular Therapy
If more than one topical ophthalmic medication is being used, advise patients to
administer BromSite at least 5 minutes after instillation of other topical medications.
Post-marketing experience with topical NSAIDs also suggests that use more than
24 hours prior to surgery or use beyond 14 days postsurgery may increase patient
risk for the occurrence and severity of corneal adverse events.
Concomitant Use of Contact Lenses
Advise patients not to wear contact lenses during administration of BromSite.
The preservative in this product, benzalkonium chloride, may be absorbed by
soft contact lenses.
Contact Lens Wear
BromSite should not be administered while wearing contact lenses. The preservative
in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses.
Sterility of Dropper Tip/Product Use
Advise patients to replace the bottle cap after use and do not touch the dropper
tip to any surface as this may contaminate the contents.
ADVERSE REACTIONS
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of another drug and may not reflect the rates observed
in clinical practice.
The most commonly reported adverse reactions in 1–8% of patients were:
anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain
and ocular hypertension.
Advise patients to thoroughly wash hands prior to using BromSite.
Rx Only
Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
BromSite is a trademark of Sun Pharma Global FZE.
SUN-OPH-BRO-017 09/2016
APRIL 1, 2017 :: Ophthalmology Times
35
Special Report )
INNOVATIONS IN
FEMTOSECOND LASER TECHNOLOGY
Femtosecond laser preserves capsule
integrity in secondary IOL exchange
Anterior capsulotomy with femtosecond laser ensures capsular bag remains usable
By Cheryl Guttman Krader; Reviewed by Samuel Masket, MD
FINDINGS FROM MULTIPLE stud- adhesions between the haptics and capsular
ies demonstrate benefits of using a femtosec- bag,” Dr. Masket said. “This case was further
ond laser for anterior capsulotomy during cat- complicated by a shrunken and fibrotic anterior capsule.
aract surgery.
“The conventional choices are to make reBuilding on that application, the femtosecond laser also provides a useful tool for creat- laxing incisions with an Nd:YAG laser in the
ing a secondary anterior capsulotomy to assist office preoperatively or with scissors intraopwith IOL exchange complicated by anterior eratively,” he explained. “Either of those apcapsule phimosis, said Sam- proaches, however, may render the capsular
bag unusable for secondary IOL implantation.
uel Masket, MD.
Crediting Surendra Basti, Using the femtosecond laser to cut a secondMD, Northwestern University, ary capsulotomy makes it possible to retain a
Chicago, for first describing normal capsular bag.”
Using the Catalys femtosecond laser and with
the procedure, Dr. Masket has
performed femtosecond laser the same parameters that he sets for primary
Dr. Masket
secondary to anterior capsulot- capsulotomy (except that the energy was inomy successfully in two patients using different creased from 6.0 to 10.0 mJ), he created a 4.8femtosecond laser platforms (Catalys Precision mm secondary anterior capsulotomy.
Once the patient was in the operating room,
Laser System, Johnson & Johnson Vision/Abbott; LenSx Laser System, Alcon Laboratories). he created a 2.2-mm temporal clear cornea inThe first case, which involved a patient who cision. He then used a microforceps to free the
was three-years post-cataract surgery, also re- laser-cut anterior capsule edge and a spatula to
inforces the importance of careful patient se- separate the anterior capsule from the underlying anterior surface of the IOL.
lection when implanting multifo“After these maneuvers, it was
cal IOLs, said Dr. Masket, clininot difficult at all to peel away
cal professor, Jules Stein Eye Inthe secondary capsulotomy,” Dr.
stitute, UCLA School of Medicine,
Masket added.
Los Angeles.
IOL exchange in eyes
With blunt and viscodissection,
The patient was a 75-year-old with anterior capsule
he separated the capsule from the
woman referred to him because of phimosis using a
anterior surface of the lens for 360°
dissatisfaction with her vision after femtosecond laser to
and elevated one edge of the optic
bilateral multifocal IOL implantation create a secondary
with a Sinskey hook.
with a three-piece, acrylic multi- anterior capsulotomy
Blunt and viscodissection were
focal IOL. The patient had ocular can allow in-the-bag
used to free the inferior haptic that
surface disease, including both epi- placement of the new
was firmly attached to regenerative
thelial basement membrane dys- IOL.
cortex. The superior haptic was
trophy and severe dry eye disease,
along with dry age-related macular degenera- free of adhesions.
The IOL was cut and removed. After ensurtion. Although her binocular BCVA was only
20/50, she was expected to benefit from the IOL ing the capsular bag was opened 360° and reexchange because her potential acuity mea- generative cortex was removed, intraoperative
aberrometry (ORA, Alcon Laboratories) was
sured with a retinal acuity meter was 20/25.
used to guide power selection for a singlepiece acrylic monofocal IOL.
CHALLENGES EXPECTED
Six months after the procedure, the monoNevertheless, Dr. Masket expected the procedure would be challenging because of signifi- focal IOL was perfectly centered, there was
no anterior capsule phimosis, and the patient
cant anterior capsule phimosis.
“Explanting an IOL after three years can be had 20/25 UCVA. The procedure was repeated
fraught with problems because there may be in the second eye with the same good result.
take-home
IOL EXCHANGE
VIDEO To watch an effective procedure
for performing an IOL exchange, go to
OphthalmologyTimes.com/IOLExchange
(Video courtesy of Samuel Masket, MD)
MA XIMIZING SUCCESS
The first patient should not have been implanted
with a multifocal IOL, Dr. Masket noted, because her ocular comorbidities made her a poor
candidate for achieving a good outcome.
“Proper patient selection, along with thorough preoperative counseling to set appropriate expectations, are two of the guiding principles for achieving patient satisfaction after
multifocal IOL implantation,” Dr. Masket said.
“Proper patient selection involves avoiding
anyone who has any of the following conditions—keratopathy, optic neuropathy, zonulopathy, pupillopathy, maculopathy, and psychopathy,” he added.
Management of cases with patients dissatisfied after multifocal IOL implantation requires
understanding of the possible causes for suboptimal outcomes, which includes residual refractive error and ocular surface disease.
“Importantly, good postoperative management skills also require that surgeons know
when and how to exchange the IOL,” Dr. Masket
said. “If everything else fails and the patient
still has poor quality vision, then it is best to
exchange the IOL.” ■
SAMUEL MASKET, MD
E: [email protected]
This article was adapted from Dr. Masket’s presentation at the 2016 meeting of the
American Society of Cataract and Refractive Surgery. He is a consultant for Alcon.
APRIL 1, 2017 :: Ophthalmology Times
36
Special Report )
INNOVATIONS IN
FEMTOSECOND LASER TECHNOLOGY
Redesigned pupil expansion device
reduces cataract surgery risks
Expansion ring aids pre-treatment, manages femtosecond laser-induced miosis
By Cheryl Guttman Krader; Reviewed by Boris Malyugin, MD, PhD
PRE-TREATMENT WITH the femto- pentolate 1% and phenylephrine 2.5% applied
second laser in eyes undergoing cataract sur- at 60, 45, and 30 minutes preoperatively.
gery can induce miosis. The use of a pupil exPupil diameter measurements immediately
pansion device, however, offers an effective before and 10 minutes after femtosecond laser
method for managing small pupils in femto- treatment using a single system (LenSx Laser
second laser-assisted cases whether the prob- System, Alcon Laboratories) showed a statistilem pre-exists or is caused by cally significant decrease (mean -1.56 ± 0.73
the laser, said Boris Malyugin, mm) from a mean of 7.79 ± 0.86 mm to 6.42
MD, PhD.
± 1.16 mm. In 11 eyes (23.4%), the pupil di“Achieving and maintaining ameter decreased to ≤ 6 mm and there was a
sufficient mydriasis is impor- decrease to ≤ 5 mm in 6 eyes (12.7%), he noted.
tant to prevent complications
“Patient compliance with use of the NSAID
during cataract surgery,” said before surgery was not checked,” he said.
Dr. Malyugin
Dr. Malyugin, professor of ophthalmology and deputy director, S. Fyodorov
SM A LL PUPIL M A NAGEMEN T
Eye Microsurgery Institution, Moscow. “Many A small pupil presents a limitation to using the
ocular and systemic comorbidities affect pupil femtosecond laser in addition to increasing the
size, and we have learned that treatment with risk of complications during cataract surgery.
the femtosecond laser, which induces release
Pupil expansion devices can be successful
of prostaglandins into the aqueous
means to allow femtosecond laser
humor, is also a cause of intraoppre-treatment in eyes with a small
erative miosis.”
pupil or to manage miosis induced
Miosis induced after femtosecby the femtosecond laser.
ond laser pre-treatment for cataA new version of a pupil expanFemtosecond
ract surgery was studied by Dr. laser treatment can
sion ring (Malyugin Ring 2.0, MiMalyugin in a series of 47 eyes of cause miosis and
croSurgical Technology), can go
47 patients undergoing surgery for be precluded by
through a smaller incision than
senile cataracts. The patients ranged insufficient mydriasis.
the original device (Malyugin Ring,
in age from 57 to 76 years (mean Use of a pupil
MicroSurgical Technology) and is
71.3 years) and had no ocular or expansion device offers
more user- and iris-friendly, Dr.
systemic comorbidities.
Malyugin said.
a solution for either
A preoperative medication regi- situation.
The new model is available in 6.25
men for achieving and maintainmm and and 7.0 mm and is made of
ing sufficient mydriasis was part of the sur- smaller-gauge material than the original (5-0
gical protocol, comprised of a topical NSAID polypropylene versus 4-0 polypropylene). This
(diclofenac sodium 0.1%) applied 3 times per makes it thinner and more flexible. The injecday starting a day before surgery plus cyclo- tor was also redesigned and is much more slim
in order to easily
pass through an
incision of only
2.0 mm, Dr. Malyugin said.
The pupil expander provides
eight points of fixation, but is more
gentle to the pupil
edge and sphinc— Boris Malyugin, MD, PhD ter because it ex-
PUPIL EXPANSION DEVICES
VIDEO Implantation of the original
expansion device following femtosecond laser
capsulotomy and lens fragmentation.
take-home
‘Insertion and removal are easy
using the injector, and after the
device is removed, the pupil
spontaneously returns to a nice,
round configuration.’
VIDEO The updated pupil expansion
device is implanted through a 2.0-mm incision
prior to FLACS. To watch both videos, go to
OphthalmologyTimes.com/MalyuginRings
(Videos courtesy of Boris Malyugin, MD, PhD)
erts less compression force. Yet, the device provides the same performance for maintaining
the enlarged circular pupil, even if the surgeon
uses aggressive phacoemulsification settings.
“There is no need to change the surgical
technique with the new generation device,”
Dr. Malyugin said. “Insertion and removal are
easy using the injector, and after the device is
removed, the pupil spontaneously returns to
a nice, round configuration.” ■
BORIS MALYUGIN, MD, PHD
E: [email protected]
This article was adapted from Dr. Malyugin’s presentation at the
2016 meeting of the American Society of Cataract and Refractive Surgery.
Dr. Malyugin holds a patent on the Malyugin Ring/Malyugin Ring 2.0.
Dr. Malyugin is a consultant and receives travel grants from Alcon
Laboratories.
OPD-Scan III
Integrated Wavefront
Aberrometer
FEMTO-PARTNER
Now the OPD-Scan III integrates with LensAR femtosecond laser system.
We welcome the opportunity to share how this unique partnership can
be an invaluable asset to your practice.
The addition of Marco OPD as an advanced diagnostic device to LENSAR with
Streamline intra-operatively has expanded the refractive cataract surgeon’s
capability in meeting patients’ visual expectations. The OPD’s capability to
separate corneal from lenticular astigmatism helps to educate patients for
astigmatic treatment planning with the LENSAR femtosecond laser platform
at the time of cataract surgery.
Mitchell A. Jackson, MD | Lake Villa, Illinois
Creating an integrated technology approach to the femtosecond cataract procedure
is something we refractive cataract surgeons have been waiting for. The addition of
the OPD-Scan III from Marco will make the patient work-up much easier. I anticipate
/(16$5ZLWK6WUHDPOLQHZLOOLPSURYHQRWRQO\25HIÀFLHQF\DQGSDWLHQWH[SHULHQFH
during the procedure, but may also improve outcomes by minimizing the human
error in manual data input or marking the eye pre-operatively.
Jonathan Solomon, MD | Bowie, Maryland
ASCRS/ASOA • 547
Designed and Manufactured by NIDEK - Represented by Marco
800-874-5274 • marco.com
APRIL 1, 2017 :: Ophthalmology Times
38
Special Report )
INNOVATIONS IN
FEMTOSECOND LASER TECHNOLOGY
Laser update aids cataract outcomes
Wireless transmission of corneal measurements improves patient, surgeon experience
By Nancy Groves; Reviewed by Jonathan Solomon, MD
A THIRD SYSTEM UPGRADE for
a femtosecond laser system for refractive cataract surgery (Streamline III, LENSAR) will
enhance the efficiency of the procedure, according to Jonathan Solomon, MD.
“I have seen a 15% reduction in the effective
phacoemulsification time (EPT) with dense
cataract since we implemented the new software,” said Dr. Solomon, medical director, Dimensions Surgery Center, Bowie, MD, and
surgical/refractive director of
Solomon Eye Physicians and
Surgeons, which has Maryland
and Virginia offices.
Dr. Solomon
“If we’re delivering any type
of energy, it’s a process inside the eye that has
to be streamlined,” he said. “It takes time for
the surgeon, it’s time inside the eye for the patient, and it could potentially have an impact
on the surgical outcome.
“The fact that you’re able to deliver your
needed laser treatment in a more efficient matter also makes the experience for the patient
a whole lot easier and more comfortable,” he
added, noting the time from the patient’s first
encounter with the upgraded laser system to
completion is less than
a minute and a half.
“Energy reduction is
one way the system has
been improved, and suThe latest series
perior imaging is an- of upgrades to a
other,” he said. “We’re femtosecond laser
able to achieve better technology (Streamline
3-D reconstruction III, LENSAR) enhance
for the relevant ante- efficiency and improve
rior segment precision surgical experience
and delivery.”
for the surgeon and
With better imaging, patient. Other features
surgeons can more eas- utilize wireless
ily create arcuate cor- technology to improve
neal incisions and more accuracy and achieve
accurately deliver laser better outcomes.
energy for the capsulotomy. It also allows energy delivery to be
refined during fragmentation.
Surgeons now also have the option of a corneal incision-only mode in which they can
perform laser corneal incisions independent of
capsulotomy and fragmentation. This feature
take-home
A
B
C
A and B. Images of the registration process highlight the value of astigmatism correction.
C. A system improvement enables wireless transfer of corneal astigmatism data measurements
(from the Cassini Corneal Shape Analyzer, i-Optics). (Photos courtesy of Jonathan Solomon, MD)
is beneficial when surgeons want to start and
stop treatment with the cornea; for example,
if the eye has a very small pupil and it might
be unsafe to treat the lens.
Wireless iris registration can be done at the
same time, and along with the wireless astigmatism data transfer feature, is designed to
produce more precise treatment planning and
more predictable results.
“When you eliminate certain variables where
there is a potential for human error and allow
the computers to talk to each other from a site
such as your office to the operating suite, and
also eliminate the time that it takes for data
transfer, that’s another potential efficiency that
comes with this upgrade,” Dr. Solomon said.
PAT IEN T E X PER IENCE
Dr. Solomon also emphasized patient experience should not be overlooked when considering the impact of technology. At his clinic,
patients are routinely asked to grade their surgical experience under the laser on a scale of
0 (no pain) to 10 (extremely uncomfortable).
“It’s usually anywhere from 0 to 2, but we
are getting a lot more 0 grades than we have
in the last four years since we’ve had the laser,
and in large part it’s because of the efficiency
of the laser and the 20 to 30 seconds of time
that they’ve been able to cut from the encounter itself,” he said.
Another feature is the ability to program
certain components of the surgical process,
such as diagnostic data.
Surgeons can input customized lens fragmentation patterns rather than rely on standardized cataract lens density grading. With customization, the laser can deliver energy to the
parts of the cataract where it is most needed.
Vector planning for astigmatism can also
be performed preoperatively and imported at
the time of surgery. ■
JONATHAN SOLOMON, MD
E: [email protected]
Dr. Solomon is a consultant for LENSAR and i-Optics.
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40
APRIL 1, 2017 :: Ophthalmology Times
clinical diagnosis
Computer-based image
analysis promising for ROP
Determination of plus disease may be as effective with automated algorithm
By Laird Harrison
omputers may make more reliable diagnoses of plus disease
in retinopathy of prematurity
(ROP) than individual clinicians, according to J. Peter
Campbell, MD, MPH.
While specialists in ROP
agree on which cases are the most severe when
shown images of babies with disease, they
often disagree about which cases should be
classified as plus disease.
Although many cases of ROP may resolve on
their own, the condition can cause blindness.
The Early Treatment for Retinopathy of Prematurity multicenter, clinical trial established
plus disease as a key criterion for determining
which infants need treatment.
“The determination of plus disease is very
important, but it’s very subjective,” said Dr.
Campbell, assistant professor, Casey Eye Institute, Oregon Health and Science University,
Portland.
C
ICROP PROTOCOL
In the 1980s, the International Classification
for Retinopathy of Prematurity (ICROP) established that venous dilation in the posterior pole
was greater than in a particular photograph
published at the time as the standard for diagnosing plus disease.
but have more arterial tortuosity and venous number of images they diagnosed as having
plus disease ranged from 6 to 29 out of the 100.
dilation than normal.
The references standard diagnosis fell in the
To see how a computer algorithm compared
with individuals and groups of clinicians, Dr. middle of the spectrum of diagnoses from these
eight experts. The researchers
Campbell and his colleagues
used the reference standard dianalyzed data on 1,553 patients.
agnosis for each image as the
To establish a reference stanA computer-based
gold standard with which to evaldard diagnosis for each patient,
imaging algorithm for
uate both the computer-based
they combined three independetecting retinopathy
algorithm and individual clinident gradings of the images
of prematuraty
cians’ diagnoses.
by three masked examiners
agreed with the
The mean weighted Cohen’s
with the clinical diagnosis
reference standard
kappa for agreement of seven
made at bedside using indidiagnosis 95% of the
clinicians at bedside with the
rect ophthalmoscopy.
time, compared with
reference standard diagnosis was
If the majority of examiners
a mean of 97% for
0.49, with a range from 0.13 to
independently agreed with the
eight experts.
0.86 (where 1.0 is perfect agreediagnosis, this consensus bement). The mean weighted kappa
came the reference standard difor agreement of three image
agnosis. If there was disagreement, the examiners discussed the image until graders with the reference standard diagnosis
they reached a consensus for the reference was 0.80 (0.68-0.91).
Based on these findings, they argued a “sinstandard diagnosis.
gle expert’s diagnosis” should not be the gold
standard for diagnosis of plus disease. Still, conNO DIFFERENCE IN
sulting with multiple experts on every diagnoDI AGNOSIS
Looking at 50 babies with plus disease, the sis is not feasible for most clinicians, he said.
As a result, Dr. Campbell and his colleagues
researchers found there was no difference on
average between the diagnosis by bedside oph- compared a computer algorithm with the refthalmoscopy and imaging grading in the de- erence standard diagnosis. They designed the
tection of plus disease. They validated this algorithm to identify vascular features that clasreference standard sify normal, pre-plus, and plus disease, using
diagnosis by send- 11 measurements of dilation and tortuosity.
On a set of 73 images, they compared the
ing the 100 images
to eight interna- results of the same eight international experts
tional experts, who and the computer algorithm with the reference
each had more than standard diagnosis. They found the experts
10 years of clinical agreed with the reference standard diagnosis
experience in ROP 79% to 99% of the time, with a mean of 97%.
and more than five
COMPUTER ALGORITHM
publications on this
Campbell, MD, MPH condition.
FAR ES W ELL
Of the experts, The computer algorithm using manually segfive were retina spe- mented images agreed with the reference stancialists and three dard diagnosis 95% of the time, which was a
were pediatric ophthalmologists. These eight better rate of agreement than all but one of
experts disagreed with each other regarding the experts.
the proper diagnoses from the images. The
Continues on page 42 : Computer
‘The determination of plus
disease is very important,
but it’s very subjective.’
— J. Peter
Since then, ICROP has established a pre-plus
category, defined as retinal vascular abnormalities that are insufficient for plus disease,
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APRIL 1, 2017 :: Ophthalmology Times
42
clinical diagnosis
COMPUTER
( Continued from page 40 )
In addition, the researchers found the computer algorithm could produce a quantitative
output indicating the degree of tortuosity and
dilation on a spectrum from mildest to most
severe disease with multiple grades in between.
APPLICATIONS FOR
TELEMEDICINE
This more granular disease scale could help
clinicians track disease progression and help
clinicians working by telemedicine to identify
babies in need of ophthalmoscopy, Dr. Campbell said.
“We’re planning to make our algorithm
freely available,” he added. “It could be an
objective measure of disease in the same way
you can go to the doctor and get a blood pressure measure.”
Dr. Campbell does not expect the algorithm
to take the place of clinical judgment.
“It gives you one more piece of information
in a way that’s more objective than your clinical exam is,” he pointed out.
The team also is working to put the algorithm in a smart phone application. Clinicians
would use the phone’s camera to capture fundus images from a monitor screen and categorize them on a scale of severity.
Although the cell phone processor will be
working with an image of an image, Dr. Campbell and his colleagues are hopeful the resolution will be sufficient for an accurate analysis.
“Until we have the app working, we don’t
know if you lose too much quality,” Dr. Campbell said. “There are a lot of exciting possibilities, and like anything we need to make sure
they work in the real world.” ■
95% versus 97%
Computer algorithm agreed
with the reference standard
diagnosis 95% of the time
compared with a mean of 97%
agreement for eight experts
WE WANT TO HEAR FROM YOU
Have a comment or question?
Submit a letter to the editor at
[email protected]
J. PETER CAMPBELL, MD, MPH
P: 503/494-7891
E: [email protected]
This article was adapted from Dr. Campbell’s presentation
at the 2016 meeting of the American Society of Retina Specialists.
Dr. Campbell reported no conflicts of interest in the subject matter.
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APRIL 1, 2017 :: Ophthalmology Times
43
clinical diagnosis
How pattern, flicker ERG can impact
cataract treatment decisions
Testing detects disease behind cataracts without relying on refraction, pattern recognition
By William Bond, MD; Special to Ophthalmology Times
RETINAL ISSUES can impact cataract
surgery outcomes, especially for those with multifocal or other premium lenses. While multifocal lenses may allow the patient to see more
clearly across a range of distances, they may
also decrease the amount of light that reaches
the retina, exacerbating any issues that may
already be present.
In addition, cataract surgery will not restore
optimal vision if the cataract is not the main
issue for the decline of visual acuity. Removing the cataract would only be treating part
of the problem.
PERG is ideal for early
detection of glaucoma
as it measures the health
of retinal ganglion cells
that may be struggling.
Knowledge of the posterior segment health
is essential prior to moving forward with cataract surgery, whether using a premium lens
or not. However, when a cataract is present, it
can be difficult to view the macula. As cataracts worsen, they may impinge on the visual
field quality and make it more difficult to determine if any other pathology must be addressed.
Even without cataracts, traditional diagnostics only provide valuable information on the
structure of the cells but do not objectively
reveal how well those cells are functioning.
Electrophysiology testing—particularly, pattern electroretinography (PERG)—solves this
issue and can be effectively and efficiently
performed with an in-office device (Diopsys
NOVA Vision Testing System, Diopsys).
A
C
B
D
E
(FIGURE 1) A and B. The pattern electroretinography (PERG) screen and in-office product. C. Full-field
electroretinography (ffERG) of patient with DME D. FfERG of patient with healthy eyes E. FfERG of patient
with opacity, no retinopathy present. (Photos courtesy of Diopsys)
While examination with optical coherence
tomography (OCT) provides valuable information, it is not always sufficient when cataracts are present. The media opacity can
render information gathered unreliable or
unobtainable.
Consequently, testing that does not rely on
the ability to detect patterns is needed.
Full-field electroretinography (ffERG), including flicker ERG do not rely on refraction or recognition of patterns and can therefore provide
the ability to detect disease behind cataracts.
WHAT AR E PERG AND
FLICKER ERG?
PERG is ideal for the early detection of glaucoma as it allows surgeons to objectively determine the health of retinal ganglion cells
and measure the function of cells that may
be struggling but are not yet dead.
The retina is stimulated by an alternating
pattern, typically horizontal bars or checks.
The response to these stimuli is recorded as
a measureable signal that provides valuable
Continues on page 46 : PERG, flicker ERG
ADVERTISEMENT
This article is brought to you by
Refractive
Cataract
Surgery:
Creating a premium experience
Tal A. Raviv, MD, FACS
Dr. Raviv is Founder and Medical
Director, Eye Center of New York,
New York, NY. He is a paid consultant
to Johnson and Johnson Vision.
ataract surgery has undergone a major
transition in the last decade as advanced
diagnostic technology, femtosecond laser,
and presbyopia/astigmatism-correcting intraocular lenses (IOLs) have ushered in a new era of
refractive cataract surgery. This shift has allowed
more patients to enjoy reduced spectacle wear
after cataract surgery, and the ability to see
without correction across a range of distances
can be truly transformational. Benefiting from this
opportunity, however, involves increased
out-of-pocket costs for patients that can lead to
heightened expectations for the receipt of
outstanding service and outcomes.
C
Guided by the concept of the “Experience
Economy,” which speaks to the need for businesses
to create a memorable experience for customers,
we sought to enhance our service and offerings by
introducing modifications in our practice communications, staff training, and office environment.1,2
Creating this experience rests on the foundation of
achieving outstanding surgical results, as measured by unparalleled refractive and functional
outcomes. Such outstanding results have been
enabled by implementation of the most-advanced
techniques and technologies, including femtosecond laser-assisted cataract surgery (FLACS) using
the CATALYS® Precision Laser System and TECNIS
Symfony® extended-depth-of-focus IOLs.
Setting the stage
Our effort to develop a premium refractive
cataract surgery practice that offers patients a
memorable experience began with attention to
been renamed “the reception lounge,” and it
provides a setting for further educating patients
about our practice and services. A flat screen
monitor video displays information about our
doctors and procedures, as well as media clips
and other practice information using subtitles
instead of audio to eliminate extraneous noise.
Cataract patients are additionally given a
tablet-based education video. The office staff
strives to provide a level of service that customers would receive at the best hotels and restaurants in New York City. Creating this memorable
experience for our patients requires continually
learning lessons from the hospitality business.
Delivering successful
clinical outcomes
creating positive initial impressions and interactions, even before patients set foot in our office.
Many of our cataract surgery patients are seen as
referrals, and in 2017, the practice doorstep has
moved online. We redesigned our practice website
with an aesthetically pleasing, modern appearance and a goal to make it engaging. Websites
should be “responsive,” meaning that they display
appropriately and are easy to navigate through
mobile devices, tablets, and personal computers.
Consideration also was given to the content of
our written communications with patients. Prior
to their preoperative visit, all cataract surgery
candidates receive a packet that provides
information about the procedure and what they
should expect at their upcoming appointment.
The material is sent by mail to new patients and
distributed at the office to existing patients who
are deemed to need cataract surgery.
Clearly, there is no premium service without a
premium surgery that can meet and exceed
patient expectations. Therefore, surgeons need to
become students of continually evolving refractive
surgery principles and stay current with advances
in techniques and technologies that enhance our
ability to achieve the desired outcomes.
First, surgeons need to educate themselves on
appropriate patient selection for presbyopiacorrecting IOLs and proper matching of individual
patient needs with the performance characteristics of different lenses. In addition, surgeons must
hone their own and their office staff’s communication processes, which will help facilitate an
informed discussion of the technology that will
This information introduces the availability of a
refractive cataract surgery package and describes
the components of that service, including IOL
options providing reduced spectacle wear and use
of the femtosecond laser and other new technologies for cataract surgery. The introductory material
prepares patients for making a decision about the
opportunity for refractive cataract surgery after
they meet with a surgeon. We believe it is helpful
for creating a mindset that recognizes refractive
cataract surgery as a premium alternative to
traditional cataract surgery.
Integral to our aim of creating a memorable
experience, we also transformed the physical
appearance of our office (with a function- and
design-oriented office renovation) so that
patients feel they are receiving care in a boutique
hotel or airline lounge rather than in a traditional
medical practice or clinic. The waiting room has
The office before and after renovation
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address our modern lifestyle needs for good
uncorrected intermediate vision. In addition,
nighttime visual disturbances that have weighed
down earlier multifocal IOL technology occur at a
low incidence with the unique optics of the
TECNIS Symfony IOLs.
The CATALYS® Precision Laser System
allow patients choosing refractive cataract
surgery to feel confident they made a wellinformed decision.
Integrating the state of the art in diagnostic
modalities, planning calculators, surgical
technologies, and IOL options has also been
critical to our surgical success. This includes use
of advanced diagnostic devices for identifying
ocular surface disease and retinal pathologies
that can limit visual outcomes. In addition, we
implement the latest generation in optical
biometry, corneal topography (able to measure
both anterior and posterior corneal astigmatism),
and the latest-generation IOL formulas that
provide the most-accurate power calculations.
The opportunity to simultaneously correct up to
2.5 diopters of preexisting corneal astigmatism
with the toric version of the TECNIS Symfony IOL
has expanded the pool of patients who are
appropriate for presbyopia-correcting IOLs.
Combined with all the other technology, we are
now performing refractive cataract surgery with
greater confidence.
Setting realistic expectations preoperatively is
the basis for achieving patient satisfaction
postoperatively. Patients must be educated about
the benefits and limitations of all IOL options, and
the information for the TECNIS Symfony IOLs
must include mention of the potential for needing
glasses to read up close or in dim light, nighttime
visual symptoms, and a refractive enhancement.
With the TECNIS Symfony IOLs, however, I find
that the preoperative counseling discussion is
simplified, and the postoperative visit has
become more positive for the surgeon and the
patient. Patients are amazed by and appreciative
of their ability to see so well at all distances.
Closing thoughts
I am performing FLACS for all of my refractive
cataract surgery cases to take advantage of its
benefits. Using the CATALYS System, I can
consistently create a capsulotomy that is
predictably circular and accurately sized, factors
which are critical for achieving the 360° IOL
overlap needed to maintain long-term positional
stability. Further, the scanned capsule function of
the CATALYS System’s 3D optical coherence
tomography (OCT) technology provides the ability
to center the anterior capsule opening on the lens
rather than on the pupil, which may be particularly desirable when implanting a toric or
presbyopia-correcting IOL. The CATALYS System
can also be used to create arcuate incisions.
Intraoperatively, I also use real-time wavefront
aberrometry for assisting with IOL power
selection and toric IOL alignment.
When it comes to recommending IOLs for patients
choosing refractive cataract surgery, the TECNIS
Symfony IOL or its toric version are my preferred
options. In my opinion, the TECNIS Symfony IOLs
bring game-changing advantages to our arsenal of
presbyopia-correcting IOLs. The novel optic design
of the TECNIS Symfony IOLs provides a continuous
range of uncorrected vision. Therefore, these IOLs
The need to pay for healthcare is becoming more
familiar to patients with the proliferation of
high-deductible insurance plans and the growing
demand for private-pay lifestyle medical
offerings. Patients choosing private-pay refractive cataract surgery will be best satisfied if they
believe they have gained value for the extra cost.
Advances in surgical techniques and technologies
have increased our ability to achieve transformational lifestyle outcomes that meet or even exceed
patient expectations, but creating a memorable
experience from first to last interaction also needs
to be part of the strategy. Introducing changes to
optimize the office environment and service
delivery provide the wrapping that completes the
premium package of our life-changing surgery.
REFERENCES
1. Pine BJ II, Gilmore JH. Welcome to the experience
economy. Harvard Business Review. July-August
1998.
2. Pine BJ, Gilmore JH. The Experience Economy:
Work is Theatre and Every Business a Stage. Boston,
MA: Harvard Business Press; 1999.
INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS
SYMFONY and TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION IOLs
Rx Only
INDICATIONS FOR USE
The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated
for primary implantation for the visual correction of aphakia, in adult patients with
less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous
lens has been removed. The lens mitigates the effects of presbyopia by providing
an extended depth of focus. Compared to an aspheric monofocal IOL, the lens
provides improved intermediate and near visual acuity, while maintaining
comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular
bag placement only. The TECNIS Symfony Toric Extended Range of Vision IOLs,
Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary
implantation for the visual correction of aphakia and for reduction of residual
refractive astigmatism in adult patients with greater than or equal to 1 diopter of
preoperative corneal astigmatism, in whom a cataractous lens has been removed.
The lens mitigates the effects of presbyopia by providing an extended depth of
focus. Compared to an aspheric monofocal IOL, the lens provides improved
intermediate and near visual acuity, while maintaining comparable distance visual
acuity. The Model Series ZXT IOLs are intended for capsular bag placement only.
WARNINGS Patients with any of the conditions described in the Directions for
Use may not be suitable candidates for an intraocular lens because the lens may
exacerbate an existing condition, may interfere with diagnosis or treatment of a
condition, or may pose an unreasonable risk to the patient’s eyesight. Lenses
should not be placed in the ciliary sulcus. May cause a reduction in contrast
sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully
inform the patient of this risk before implanting the lens. Special consideration
should be made in patients with macular disease, amblyopia, corneal
irregularities, or other ocular disease. Inform patients to exercise special caution
when driving at night or in poor visibility conditions. Some visual effects may be
expected due to the lens design, including: a perception of halos, glare, or
starbursts around lights under nighttime conditions. These will be bothersome or
very bothersome in some people, particularly in low-illumination conditions, and
on rare occasions, may be significant enough that the patient may request
removal of the IOL. Rotation of the Tecnis Symfony Toric IOLs away from their
intended axis can reduce their astigmatic correction, and misalignment >30°
may increase postoperative refractive cylinder. If necessary, lens repositioning
should occur as early as possible prior to lens encapsulation.
PRECAUTIONS Interpret results with caution when refracting using
autorefractors or wavefront aberrometers that utilize infrared light, or when
performing a duochrome test. Confirmation of refraction with maximum plus
manifest refraction technique is recommended. The ability to perform some eye
treatments (e.g. retinal photocoagulation) may be affected by the optical design.
Target emmetropia for optimum visual performance. Care should be taken to
achieve IOL centration, as lens decentration may result in a patient experiencing
visual disturbances under certain lighting conditions. For the Tecnis Symfony
Toric IOL, variability in any preoperative surgical parameters (e.g. keratometric
cylinder, incision location, surgeon’s estimated surgically induced astigmatism
and biometry) can influence patient outcomes. Carefully remove all viscoelastic
and do not over-inflate the capsular bag at the end of the case to prevent lens
rotation.
SERIOUS ADVERSE EVENTS The most frequently reported serious adverse
events that occurred during the clinical trial of the Tecnis Symfony lens were
cystoid macular edema (2 eyes, 0.7%) and surgical reintervention (treatment
injections for cystoid macular edema and endophthalmitis, 2 eyes, 0.7%). No
lens-related adverse events occurred during the trial.
ATTENTION: Reference the Directions for Use for a complete listing of
Indications and Important Safety Information.
INDICATION The CATALYS® Precision Laser System is indicated for use in
patients undergoing cataract surgery for removal of the crystalline lens. Intended
uses in cataract surgery include anterior capsulotomy, phacofragmentation, and
the creation of single plane and multi-plane arc cuts/incisions in the cornea, each
of which may be performed either individually or consecutively during the same
procedure.
CONTRAINDICATIONS The CATALYS® System should not be used if you are
not a candidate for cataract surgery, have certain pre-existing corneal problems
or eye implants; or if you are younger than 22 years of age. Tell your doctor about
any eye-related conditions, injuries, or surgeries
PRECAUTIONS Patients must be able to lie flat on their backs and motionless
during the procedure. Patients must be able to tolerate local or topical
anesthesia. Tell your doctor if you are taking any medications such as alpha
blockers (like Flomax® to treat an enlarged prostate) as these medications may
affect how the doctor does the cataract surgery.
ADVERSE EFFECTS Complications associated with the CATALYS® System
include mild broken blood vessels or redness on the white part of your eye, which
may last for a few weeks. Other potential risks associated with cataract surgery
may occur. These risks may include but are not limited to corneal swelling and/or
abrasion, lens capsular tear, infection, inflammation, eye discomfort, reduced
vision. Talk to your doctor regarding all the potential risks associated with these
procedures.
CAUTION Federal law (USA) restricts this device to sale by or on the order of a
physician.
ATTENTION Reference the Directions for Use for a complete listing of indications,
warnings, and precautions.
© 2017 Abbott Medical Optics Inc. CATALYS and TECNIS Symfony are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. All other trademarks are the intellectual property of their respective owners.
PP2017CT0265
APRIL 1, 2017 :: Ophthalmology Times
46
clinical diagnosis
PERG, FLICKER ERG
A
B
( Continued from page 43 )
information on cell dysfunction. This allows
for earlier detection of disease, particularly
in glaucoma suspects.
As abnormalities from dysfunctional cells
can be detected up to eight years sooner than
structural tests,1 this provides the possibility
for earlier and more effective treatments and
a greater ability to slow disease progression
and improve cell health.
For patients with early nuclear sclerosis,
some information can be gathered with PERG
testing, however, ffERG—particularly flicker
ERG—is even more beneficial.
Flicker ERG tests retinal function by stimulating the entire retina with alternating flashes
of light at a rate of 32 Hz. This makes it possible to analyze the coordination between
cone cells as the rods do not respond to that
frequency of stimulus.
The intensity of the stimulus makes this
test useful for tracking disease and treatment
efficacy. Preliminary studies2 show better responses indicate a better probability for improved functional vision after cataract surgery.
This is true in my practice as well, I have
found. Because most premium lenses are
not compatible with retinopathy, the ability to determine pertinent information about
the responsiveness of the cones, even in the
C
(FIGURE 2) A. A technician administers
the in-office full-field electroretinography
(ffERG) test. B. Close-up view of a patient
undergoing testing. C. FfERG stimulates
the retina with alternating light flashes at
a rate of 32 Hz. (Photos courtesy of Diopsys)
PERG will not only detect glaucoma issues
much earlier than other diagnostics, it is also
excellent for tracking early to moderate disease
and treatment efficacy. I still perform visual
field testing in conjunction with the PERG.
A good way to think of it is that a visual
field tells where the patient has been and the
PERG tells where the patient
is going. We repeat these tests
on a yearly basis in order to
track disease progression and
treatment efficacy.
Patients with a sufficiently
dense cataract that prevents
me from adequately viewing the retina are excellent
candidates for flicker ERG.
About 50 to 65% of my cataract patients fall into this
category.
Of these, results of the test
determine the necessity to
change our planned surgical course in about
20% of cases.
These tests are not only easy to read and
interpret, but also very reliable. I have not experienced any false results and to date have
not found a comparable test. It is also efficient
and convenient.
The disposable electrodes can be used for
both tests, so if either test is indicated, both
will be performed in a convenient process.
This ensures we are detecting any possible
‘A good way to think of it is
a visual field tells where the
patient has been and the
PERG tells where the patient
is going.’ — William Bond, MD
presence of media opacities, is invaluable for
diagnostic purposes, treatment projections,
and to generate more accurate expectations
for patients.
PAT IEN T SELECT ION
I routinely see about 9,000 patients a year.
I do not perform PERG or flicker ERG on all
of my patients, however, I will use PERG for
any patient who has glaucoma or is a glaucoma suspect.
glaucoma concerns and testing for other retinal issues that may affect the outcomes of
cataract surgery.
I have found the flicker ERG in particular
to be reliable where other diagnostics are not.
My technicians perform the testing in the office and the results have allowed us to improve
outcomes for our patients. At the end of the
day, that is what it is all about. ■
References
1. Banitt MR, Ventura LM, Feuer WJ, et al. Progressive
loss of retinal ganglion cell function precedes
structural loss by several years in glaucoma suspects.
Invest Ophthalmol & Vis Sci 2013;2346–2352.
2. Mackool RJ and Mackool Jr. RJ. Evaluating macular
function before cataract surgery. CRST. June 2016;
56–57.
WILLIAM BOND, MD
E: [email protected]
Dr. Bond is medical director of Bond Eye Associates in Peoria, IL, and
is assistant clinical professor at the University of Illinois Medical
School in Peoria, IL. Dr. Bond is a consultant and speaker for Diopsys.
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Page 2
APRIL 1, 2017 :: Ophthalmology Times
drug therapy
Sustained-release implant
slows progression of DR
FAc intravitreal implant significantly prolonged time to first PDR event, show analyses
By Cheryl Guttman Krader; Reviewed by Peter A. Campochiaro, MD, and Charles C. Wykoff, MD
ustained intraocular delivery of fluocinolone acetonide
(FAc) using a FAc
0.19 mg intravitreal implant (Iluvien, Alimera Sciences) improves and slows progression of diabetic retinopathy (DR),
according to findings of post-hoc
analyses of data from the Fluocinolone Acetonide for Diabetic Macular Edema (FAME) trials.
“DR leads to progressive retinal vascular damage and local
ischemia, ultimately causing vision loss primarily through diabetic macular edema (DME) and
proliferative diabetic retinopathy
(PDR),” said Charles C. Wykoff,
MD, Retina Consultants Houston,
Houston, and FAME investigator.
“Secondary analyses of the phase
III trials leading to FDA-approval of
ranibizumab (Lucentis, Genentech)
and aflibercept (Eylea, Regeneron)
also showed anti-vascular endothelial growth factor [VEGF] treatments can significantly blunt the
progression of non-PDR to PDR.”
The implant provides a similar
benefit with a greatly reduced patient treatment burden. In the FAME
trials, patients received an average of 1.3 injections over 3 years,
whereas anti-VEGF agents were administered monthly to bimonthly.
“In eyes with DR, there is an
increase in leukocyte adhesion to
retinal vascular endothelial cells
that leads to endothelial cell damage, leukocytic plugging, and vessel closure, all of which contributes
to progression of DR,” said Peter
A. Campochiaro, MD, professor,
Wilmer Eye Institute, Johns Hopkins University School of Medicine,
S
Baltimore, and FAME investigator.
“Reduction of leukocyte recruitment in diabetic eyes is the likely
mechanism by which the FAc intravitreal implant slows DR progression, and sustained delivery
of low levels of steroid in the eye
are ideal for this indication.”
“The long-acting, slow-release,
steady-state effects of the FAc intravitreal implant will have a substantial role to play as the focus in our
field continues to shift from solely
treating DME and PDR to managing the underlying pathophysiology
of DR itself,” Dr. Wykoff added.
FAME FINDINGS
FAME trials were composed of two
identically designed, randomized,
double-masked, 3-year trials that
enrolled patients with persistent
DME after at least one macular
laser photocoagulation treatment.
A total of 376 patients were implanted with the FAc implant which
releases 0.2 mcg/day of the corticosteroid. In the control group, 185
patients received sham injection.
Re-treatment was allowed beginning at month 12 if patients experienced a ≥5-letter loss in bestcorrected visual acuity or foveal
thickness increase ≥50 μm from
the lowest measure in the previous 12 months.
At enrollment, 60% of patients
across the FAc and sham groups
had NPDR, which was graded as
moderately severe to severe (levels 47 to 53).
Assessments of the implant’s effect on DR status included analyses
of time to first PDR event and of
changes in diabetic retinopathy severity scale (DRSS) step according
to baseline DRSS level and baseline
(FIGURE 1) The fluocinolone acetonide (FAc) 0.19 mg
intravitreal implant delivers 0.2 mcg/day of the
corticosteroid. (Image courtesy of Alimera Sciences)
Designed to deliver
FAc for 36 months
Non-permeable cap
Permeable membrane
of polyvinyl alcohol
0.37 mm
diameter
48
Nonbioerodable tube
of polyimide
Internal matrix containing 0.19 mg
of fluocinolone acetonide
3.5 mm length
retinal perfusion status. PDR progression was defined as a change
from NPDR to PDR, need for panretinal photocoagulation, or need
for pars plana vitrectomy for PDR.
PROLONGED TIME
TO PDR EVENT
Mean time to first PDR event was
significantly later in the FAc implant
group compared with the controls
(p < 0.001). Subgroup analyses considering eyes with different DRSS
levels at baseline also showed significant prolongation in the time
to first PDR event in FAc-treated
eyes compared with controls in
eyes with baseline DRSS levels of
47 to 53 and 60 to 75 (mild PDR to
high-risk PDR).
The implant significantly prolonged the time to first PDR event
in eyes with and without retinal
nonperfusion. The greatest benefit was achieved in the subgroups
most at-risk for PDR progression.
Using data from the entire population, numeric differences favoring
FAc over sham were also found in
analyses of the proportion of patients achieving a ≥2-step or ≥3step improvement in DRSS score,
although the differences between
treatment groups did not achieve
statistical significance. ■
PETER A. CAMPOCHIARO, MD
E: [email protected]
Dr. Campochiaro is a consultant to Alimera Sciences.
CHARLES C. WYKOFF, MD
E: [email protected]
Dr. Wykoff receives financial support from Alimera Sciences.
APRIL 1, 2017 :: Ophthalmology Times
49
drug therapy
‘Ideal’ disease management leads
to better neovascular AMD outcomes
PRN, treat-and-extend studies lend support for AMD home monitoring
By Michelle Dalton, ELS
NEOVASCULAR age-related
macular degeneration (AMD) is well
known as a heterogeneous disease with
variable natural history and variable
treatment response, said Carl D. Regillo, MD, FACS. Many patients do well
without monthly treatment as noted
in HARBOR as-needed (PRN) arms.
“It’s well known patients in this
study did well on both ends of the
spectrum,” said Dr. Regillo, director
of the retina service, Wills Eye Hospital, Philadelphia. “Frequent fixed
dosing, as were done in the registration studies for aflibercept (Eylea, Regeneron Pharmaceuticals) and ranibizumab (Lucentis, Genentech), does
lead to some degree of overtreatment
and overtreatment does translate into
increased expense burden and risk.”
Individualized treatment in attempts
to avoid overtreatment can be accomplished by PRN, treat-and-extend, or
a combination of the two “with the
goal of suppression of both choroidal
neovascularization growth and exudation,” Dr. Regillo said, adding that
it requires frequent optical coherence
tomography (OCT) testing with a zero
tolerance for exudation.
STUDIES SUPPORT PR N
Both the CATT and IVAN studies confirmed PRN treatment “does work well
in many patients,” Dr. Regillo said.
For many patients, PRN regimens are
impractical as dosing is reduced, but
not office visits.
“Even with close monitoring, the
best available imaging techniques—
and a zero tolerance for any signs of
recurrent exudation—CATT, IVAN, and
HARBOR studies indicated the PRN
approach doesn’t control the disease
as well over time,” he explained. “The
visual improvements achieved early
in the course of treatment didn’t hold
up as well as continuous treatment.”
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Some vision loss in the long-term
study cohorts may be related to undertreatment, but small lesions at baseline and baseline vision are predictors
of final visual acuity.
“If patients start off with good vision, they’ll end with even better vision,” Dr. Regillo said.
In a recently published study in patients with 20/40 or better baseline vision, vision can be maintained over 2
years in more than 75% of patients,
he added.
E A R LY DE T E C T ION
“The reality in practice is that we don’t
catch wet AMD very early on when
the vision is very good, at 20/40 or
better,” he said. “Studies show we're
doing this probably only 20 to 40%
of the time. We have to do better.”
Among his suggestions included
public awareness programs, patient
education, and compliance with homemonitoring programs, which should
make a favorable impact, he noted.
The Home Monitoring of the Eye
study with a home monitoring device
(ForeseeHome AMD Monitor, Notal
Vision) found 87% of patients with
20/40 or better vision at the time of
choroidal neovascularization diagnosis, he said.
“Regular use of such a device has
the potential to find or pick up wet
AMD when the visual acuity is 20/40
or better in close to 90% of the time,
which is far better than what we could
do in the past,” Dr. Regillo said. ■
CARL D. REGILLO, MD, FACS
E: [email protected]
This article was adapted from Dr. Regillo’s presentation during Retina
Subspecialty Day at the 2016 meeting of the American Academy
of Ophthalmology. Dr. Regillo is a consultant and speaker
for Genentech, Notal Vision, and Regeneron Pharmaceuticals.
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50
APRIL 1, 2017 :: Ophthalmology Times
practice management
Blocked clinic flow can be
analogous to a beaver dam
Analyzing root cause of poor clinic flow sheds light on poor front desk, technician relations
Putting It in View By Dianna E. Graves, COMT, BS Ed
“Beaver dams are built to provide ponds a means
of protection against predators (coyotes, wolves,
and bears) and to provide easy access to food
during winter. Dams modify the natural environment in such a way that the overall ecosystem builds upon the change. While this can be
a very positive change—beaver dams can also
be very disruptive. Flooding can cause extensive
property damage. But on a whole, dam building can be very beneficial in restoring wetlands.
While beavers can create damage, part of the
problem is one of perception and time scale.”1
aving grown up in a rural
community in western Massachusetts, all the children—and dogs—were very
aware of beaver dams.
We kids looked at the
dams as forts to conquer and
sit on during the day as the beavers swam
aggressively around trying to keep us away.
The dogs often looked at the dams as
areas to conquer so they could capture the
beavers. Unfortunately, they usually spent
their days unsuccessfully stalking the beavers, and more often, being bit or chased
from the water by a pair of angry buckteeth.
The only reward our English setter ever
achieved for hunting skills was “horse blue
antiseptic,” which would be applied to the
ill-timed teeth marks all over its body. And
the next day—the dog would be right back
there to try again in vain.
H
I never thought after I entered the field
of ophthalmology that I would give beaver
dams much thought again—but here we are
analyzing the clinic flow in these terms.
In this day of electronic health records
(EHRs)—where the ultimate
goal of an EHR was to ensure
our clinic lives went quicker
and would be less bogsome—
clinic flow has never been
slower.
These very systems have
actually decreased production time, increased expenses, and decreased physician, staff, and ultimately
patient satisfaction, due to
the “dams” which have been
erected.
What was once a theoretical benefit of
the dam is now causing chaos all the way
downstream.
never works and usually only muddies the
waters more. I have learned to shrug my
shoulders and live another 15 minutes by
saving my breath, but it is still a valid question. It goes back to being about beaver dams.
Being behind on the clinic
schedule is not a potential
life or death situation, but try
telling that to the technician
who is under the gun to get
patients to the doctor.
FRONT DESK,
TECHNICIAN ANIMOSITY
The other day, one of my doctors came in
and asked why there was such animosity
between the front desk associates and technicians—in essence: “Why don’t they like
each other?”
I have spent a good part of my career trying to explain this to vice presidents, administrators, and doctors—people who are neither technician nor front desk members. It
Meaningful use and government mandates have added blocks all throughout
the system that continue to add more and
more time to each patient visit—and ends
up damming up the clinic from ever getting
their hands on the patient to do the exam.
In most offices, the patient spends an exorbitant amount of time discussing insurance information, vision plan insurance
proof, HIPAA information, billing information, and woe be it if he or she needs an
interpreter or needs to have a future test
scheduled.
A patient can check in for an 8:30 a.m. appointment and the technician is still waiting
Virtual, augmented reality opening doors for ophthalmic apps
USING BOTH virtual and augmented reality, a smartphone app (In My Eyes, Regeneron/Intouch Solutions) provides a visual representation of how the world looks to patients
with three different retinal diseases: wet agerelated macular degeneration, diabetic macular
edema, and macular edema following retinal
vein occlusion. The tool can be used for physicians and patients to share a virtual experience
of what it is like to live with the eye disease.
The app is available for download on Google
Play and iTunes. Once downloaded, the app
is very simple to use and can work with or
without a headset.
For each disease, the user can apply story
mode, in which the user is seeing from the perspective of the patient, or live mode, in which
the app accesses the phone’s camera and the
symptoms of the disease show against what
the camera sees. It allows the user to have a
real-time, in-the-moment experience. ■
APRIL 1, 2017 :: Ophthalmology Times
51
practice management
to receive his or her paperwork and
get them going at 9 a.m.
They are usually very good friends
and have great relationships when
not at work.
When the system breaks down,
A ‘DAM' SCENARIO
the effects are far reaching, and
Here is how it potentially goes: A
will continue to cause problems all
patient arrives to the clinic and
the way down the stream. Think of
has forgotten his or her new insurit in this fashion: If an earthquake
ance or vision plan card. This now
occurs on an island, a ripple will
creates an issue in regard to the
occur in the ocean
clinic getting reimwhere the earthbursed. Add that the
quake was centered.
interpreter is late—
Understanding the
That ripple will conon top of the 15 minsource of blockedtinue throughout the
utes the patient is
up clinic flow can
ocean so that by the
late—and we begin
alleviate tense
time it gets hundreds
to see a ripple effect
relationships between
of miles away, that
downstream.
employees while
small ripple now has
Meanwhile, the
improving patient
the potential to betechnicians are waitsatisfaction and
come a tsunami—full
ing in the back to get
retention with a more
of devastation.
their hands on the
efficient process.
While being behind
patient.
the clinic schedule is
Let’s say that panot a potential life or
tient is a visual field
death situation, try telling that to
patient. If the patient is 15 minutes
the technician who is under the gun
late, the process holds him or her
to get patients to the doctor.
another 15 to 20 minutes, and by
the time the technician gets the paBLOW ING UP THE DAM
tient, the next visual field patient
Your clinic flow can be easily
is already 10 minutes delayed and
equated to a beaver dam. Evaluate
starting to get irritated.
the clinic as to the processes you
The last issue to deal with as a
have and where they dam up. Evalresult of the system delay is the
uate the effect it has downstream
technician “standing around” and
and work to avert those issues.
the doctor becoming angry because
If the issues cannot be diverted,
he or she will ultimately have six
you need to evaluate the need to
patients ready at the same time.
“blow up the beaver dam” and start
The whole process (the dam)
anew—to prevent the problems
causes a backup in the clinic (flooddown-stream (flow, patient satisfacing of a pond), which, eventually,
tion, and patient retention).
when loosened up (patient is now
If you continue to muddle
moving in the system), causes the
through with a dammed up system,
farmer’s field down the stream to
buy a lot of “horse blue” and preflood and ruin the new corn crop
pare to spend the majority of your
(patient satisfaction).
days putting it on the beaver bites
Because of these continued dethat will occur between the technilays, the staff will begin to “feed
cians and the front desk—as there
off” of, and “chew” on the peowill be many.
ple they perceive are in the way of
Lastly, remember: if you choose
being able to do their job.
to blow up the beaver dam to alleviWhen the technicians sense the
ate these issues—beavers are creadoctors are unhappy, they will go
tures of habit.
and harass the front desk to get
Even after life calms down and
them to turn the patient loose. The
things starts to improve at the
front desk employee feels caught in
clinic, the beaver will build another
the middle of doing their job and
dam in the same spot. It is comfortholding the technician up.
able to them, and it is safe for them
And that is why front desk emto return to. It will cause the same
ployees and technicians often do
problems, in the same places, down
not like each other while at work.
TAKE-HOME
the line, making it one ‘dam’
thing after another! ■
Reference
1. https://en.wikipedia.org/wiki/
Beaver_dam
DIANNA E. GRAVES,
COMT, BS ED
E: [email protected]
Dianna Graves is clinical services
manager at St. Paul Eye Clinic PA, in Woodbury, MN.
Graves is a graduate of the School of Ophthalmic
Medical Technology, St. Paul, MN, and has been a
member of its teaching faculty since 1983.
52
April 1, 2017 :: Ophthalmology Times
practice management
AAO initiatives placing focus
on building culture of patient safety
Avoiding healthcare errors, malpractice claims at core of ophthalmic challenge
By Cheryl Guttman Krader
Recognizing that healthcare errors impact one in every ten patients around
the world, the World Health Organization has
called patient safety an endemic concern, said
Richard L. Abbott, MD.
As the lead speaker in a recent symposium on
safety in the clinic and the operating room, Dr.
Abbott presented data highlighting the scope
of the problem in ophthalmology and talked
about the patient safety initiative of the American Academy of Ophthalmology (AAO).
“Our challenge today and going forward is
to build a culture of safety in ophthalmology,”
said Dr. Abbott, Thomas W. Boyden Endowed
Chair in Ophthalmology, University of California at San Francisco.
Patient safety has emerged as a new healthcare discipline that emphasizes the reporting,
analysis, and prevention of medical errors that
often lead to adverse healthcare events, Dr.
Abbott explained.
“Serious mistakes are made in diagnosis,
prescribing of medications, communication,
and surgery, and we need some data so we
know the most harmful ambulatory safety issues in order to create and implement a corrective plan with achievable goals,” he said.
As evidence of the mistakes, Dr. Abbott presented data from the IRIS Registry showing
that between 2013 and 2014, of the almost
6.5 million patients captured in the database,
0.71% had a medical error, translating into
about 4,600 events.
Cataract fragments left in the eye accounted
for the vast majority of those errors (n = 4,498),
in case you
missed it
and he noted the importance of cataract surgery has to do with the volume of procedures
performed.
“We are now looking at a total of 20 million
unique patients in the database, and so these
numbers are much greater and we are dealing
with a significant problem,” Dr. Abbott said.
“We hope the IRIS Registry will give us more
information and help us pinpoint where the
medical errors occur.”
M a lpr actice cl a ims data
Presenting medical malpractice claims data
from the Ophthalmic Mutual Insurance Company (OMIC), Dr. Abbott said there have been
more than 4,000 closed claims and lawsuits
in the database since 1987.
As would be expected based on relative
case volume, the largest percentage of claims
and of paid claims involved cataract surgery
procedures.
Improper performance of surgery accounted
for over 50% of the claim allegations, while
diagnostic error was the allegation in almost
14% of claims.
A look at indemnity paid showed diagnostic
error assumed even greater importance, while
eight of the top ten largest claims paid by OMIC
over the past years had to do with misdiagnosis or diagnosis failure and diagnostic error.
“This means there is more financial reward
given to patients where there is a diagnostic
error,” Dr. Abbott said. “Therefore, in looking
at our education and in the ways we practice,
diagnosis is a key issue in patient safety.
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cataract surgery Page 28
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“We think we have a unique opportunity
in ophthalmology, and the AAO is working
with many organizations both in the United
States and globally to build a culture of patient safety,” Dr. Abbott said. “We have a very
strong interest in leading efforts to improve
patient safety and avoid medical errors in the
clinical practice setting.”
He noted that the AAO is working with the
American Board of Ophthalmology to build
a culture of patient safety. In addition, at the
2015 meeting of the AAO, the Global Alliance
Secretariat chaired a meeting in which international ophthalmology leaders discussed the
best ways to proceed in building a global patient safety culture.
Other components of the AAO’s patient safety
initiative include patient safety symposia being
offered at the annual meeting, all Supranational
Society meetings in 2017, and the World Ophthalmology Congress in 2018.
A host of other resources related to patient
safety are also available from the AAO. In addition to the IRIS Registry, they include the Preferred Practice Pattern guidelines, technology
assessments, patient safety statements, patient
educational materials, and risk management
tips from OMIC. ■
richard L. abbott, md
p: 415/502-6265 e: [email protected]
This article was adapted from Dr. Abbott's presentation at the 2016 meeting
of the American Academy of Ophthalmology. Dr. Abbott is a board member of OMIC
and receives honoraria and travel support for presentations and meetings.
next issue...
ARVO 2017 Meeting Preview
Special Report: New Horizons
in the Treatment of Uveitis
Keys to Manage Cataracts and
Glaucoma in Uveitic Cases
IN DISPENSABLE
53
( In Brief )
Social collection
SAFILO DIGITAL MUSEUM
DEDICATED TO EYEWEAR
3 steps to script
for second-pair sales
Patients’ needs dictate solutions offered in dispensary
By Lisa Frye, ABOC
hink about what gets your attention when you shop. Do you
spend more money to upgrade to
a newer or better product when
you recognize its benefits? Your
patients need to approach buying
eyewear in the same way.
Help patients recognize benefits by using
scripts in the optical dispensary. Optical staff
can apply the art of offering multiple pairs of
eyeglasses to patients. I call the technique “scripting for seconds,” and it involves three steps.
(Shutterstock / bernatets photo; GalleriaSafilo.com)
T
STEP
1
Telephone
Successful optical scripting starts
with the first telephone contact with
the patient.
When scheduling patients, ask them to bring
all of their eyewear to their appointment. For
example, your scheduler might say, “The doctor and technicians will want to read the prescription in your sunglasses as well as any
reading, distance, or multifocal eyewear that
you currently use.”
If the patient has only one pair of glasses,
the thought process begins of why he or she
has only one pair.
STEP
2
Examination
The next step in scripting takes place
at the beginning of the exam. The
patient lists on the intake form a chief complaint, or may mention to the technician a
problem, such as difficulty in seeing distance
or near. However, because our busy lives involve many visual challenges, many other
Continues on page 54 : Second-pair
SAFILO GROUP launches GalleriaSafilo.com,
a digital museum entirely dedicated to eyewear, its history, and technology.
The Cloud-based digital project allows visitors to discover, experience, and share the
wonder of a museum visit from their preferred
device, making the most of social networks
with intuitive features and language, according to a prepared statement.
Every guest visiting GalleriaSafilo.com will
have the opportunity to register and create a
personal gallery, selecting and downloading
the favorite pieces from the 300 unique pieces
of Safilo’s permanent collection on display.
This includes eye glasses that belonged to
Elvis Presley, Madonna, and Elton John, as
well as ancient and contemporary artworks—
all classified by genre (ancient, modern, active, celebrities, lifestyle, art, and science),
historical period (from the seventeenth to the
twenty-first century), brand (Safilo, Polaroid,
Carrera, Smith)—that can be shared in social
networks, tagging friends and involving them
in the discovery.
In addition to the permanent collection—
which will be progressively enriched by showcasing additional items from the collection of
3,000 pieces—GalleriaSafilo.com will propose
a calendar of events and temporary exhibitions,
dedicated to locations, personalities, new or
unseen objects particularly significant for the
eyewear world.
This is an opportunity that Safilo offers also
to its customers, collectors, and fashion brands
that wish to collaborate and make use of this
unique exhibition space, which can be consulted worldwide, according to the company. ■
APRIL 1, 2017 :: Ophthalmology Times
54
indispensable
the direction needed in dispensing solution
eyewear. Hearing their priorities can validate
you in your patients’ eyes.
Communicating involves the patient shar( Continued from page 53 )
ing his or her needs and you translating those
needs may require discussion. Solutions can needs into beneficial eyewear solutions. If you
are too focused on delivering your product
involve more than one prescription.
Patient education on these visual challenges spiel and treat every patient identically, you
is necessary to reveal the needs as well as the will miss opportunities to present individualpossible solutions. Patients may not understand ized solutions that can be met only with adthat what is accepted as normal (such as excess ditional pairs of eyewear.
In the optical, I begin my conversation by
glare) may in fact be correctable.
When all patient needs are addressed, you recapping what the eyecare practitioner shared
in the patient handoff. I then ask the patient
open the opportunity to script for seconds.
about any other needs or concerns. Asking
questions followed by patiently listening allows me time to digest what is revealed in the
STEP
form of needs. From the conversation, I can
The final step takes place in the opti- see the potential solutions and get a feel for
cal. Technicians and eyecare practi- which direction to proceed.
During this time, my focus is on the patient
tioners are able to pave the way by providing
the optician with list of needs for the patient. in front of me. He or she needs my undivided
For example, the tech may communicate that attention in order to fully receive the required
the patient is an avid fisherman who would solutions. I am listening to better understand
benefit from polarized lenses. Another patient his or her needs, not simply listening in order
may have ripening cataracts not yet ready for to “cookie cutter” back my response.
The best way to develop the idea of multisurgery, and premium anti-reflective lenses
ple pairs is to tell the patient
would help.
up front that you would love
Eyecare providers and techthe opportunity to educate him
nicians who share this inforMeet patient needs
on the latest products. Prodmation in front of the patient
by offering solutions
uct examples might include sun
during the patient handoff help
of multiple pairs of
protection, the latest computer
clarify solutions to the patient.
eyewear. Start when
specialized eyewear, or prodThis, in turn, helps justify the
the appointment
ucts that make a digital qualoptical staff recommendation
is made by asking
ity difference in performance.
of multiple pairs to address pathe patient to
Let’s say that you have tasktient needs.
bring all pairs of
specific solutions for a need you
The reward of making a difeyewear, including
heard mentioned. Simply openference in our patients’ lives
sunglasses, to the
ing the dialogue assumes the
through improved vision movisit. Uncover patient
need for multiple pairs, which
tivates us to do more to meet
needs during the
creates a culture for seconds.
all of their visual needs. This
exam. Communicate
Try this with every patient every
means more pairs for optimal
those needs to the
time. You may be surprised at
visual performance. Multiple sooptician during the
how many patients you can
lutions involve multiple pairs.
patient handoff.
make happy by solving their
Eyewear dispensing is a balPrescribe solutionneeds with additional pairs of
ance between identifying needs
based eyewear based
eyewear.
while offering solutions. In adon listening to the
Some patients respond to the
dition, let’s not forget the fashpatient’s needs.
analogy that he or she likely
ion aspect of eyewear and sunhas more than one pair of shoes
wear. Some patients are more
and different shoes for differinterested in the latest fashion
or technology; they may see eyewear more as ent needs. I like to say we get only one set of
eyes. We should take care of our eyes, protect
a “want” than a “need.”
them outdoors, and help them visually relax
instead of strain.
UNDERSTANDING
Put emphasis on safety as well as functionPAT IE N T N EEDS
The most crucial aspect of scripting for sec- ality. If your patient spends many hours a day
onds involves using your ears more than your on the computer, recommend that he or she
mouth. By listening, we can better understand shield the eyes with specific computer lenses
SECOND-PAIR
3
Optical
TAKE-HOME
Three steps
to scripting
1
When scheduling appointments, ask
patients to bring in all of their eyewear,
including sunglasses as well as reading,
distance, and multifocal eyewear
2
3
Discuss chief complaint and other visual
needs at the start and during exam
Eyecare practitioner and/or technician
provide the optician with a list of the
patient needs
with blue-light protection. If you have patients
who golf, suggest eyewear for safety, provide
the perfect tint in sunglasses for viewing the
ball on the green, and by all means recommend golf-specific progressive lenses so they
can read the scorecard but not interfere with
their swing.
Meeting patients’ needs may lead to their
purchasing additional visual correction, such as
contact lenses, progressives, computer glasses,
makeup glasses, and more.
Let’s not forget we have an option to create
a “want” as well. Fashion and fun are synonymous with eyewear trends. The more appealing your dispensary and frames, the more
likely patients will be drawn to the colors and
styles, and they will want that special pair.
Always discuss benefits before price. One
way to make multiple solutions affordable and
appealing is to offer a savings for volume purchases. You may want to consider offering a
second or multiple pair coupon savings or
discounts.
LEAR N WHAT WORKS
Think back on times you were motivated to
offer multiple pairs. Remember that the patient is the focus; we want to satisfy his or her
every need. Think of the needs you uncover,
find solutions, and demonstrate with multiplepair solutions. Script for seconds by practicing
until more than one is the norm. ■
This article originally appeared in
OptometryTimes.com/SecondPair
LISA FRYE, ABOC
Frye is certified by the American Board of Opticians and is a fellow
of the National Academy of Opticians.
Cutting-edge advancements
for today’s ophthalmologist,
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Introducing the Ophthalmology Times app for
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APRIL 1, 2017 :: Ophthalmology Times
56
indispensable
How might Essilor-Luxottica merger
reshape ophthalmic landscape?
Dispensary impact may be guided by focus on medically based solutions, commoditization
Dispensing Solutions By Arthur De Gennaro and Aron M. Arkon
THE RECENTLY announced merger
between Luxottica—the world’s largest
frame manufacturer—and Essilor—the
world’s largest lens manufacturer—is considered by most to be a mega-merger. It will
surely have an impact on all “three Os”
(ophthalmologists, optometrists, opticians)
in years to come.
The proposed $51 billion merger will create the largest vertically integrated supplier
of frames, lenses, and optical laboratory services in the United States.
In addition, the new company will have
in its portfolio a number of large buying
groups, the second-largest book of managed
vision-care business in the United States,
and online eyeglass shopping entities. Impressive, to be sure.
sparked Essilor’s competitors to fight to gain
more resilient to market pressures.
> Increased emphasis on online eyewear purmarket share, at a time when Essilor must
focus on retaining market share. The net
chases, starting with improving the multichaneffect for an ophthalmology dispensary is
nel sales for LensCrafters.
> Inclusion of MD-specific input into
healthy competition. This is resulting in some very attractive
wellness marketing and new proddeals being offered. It may be
uct development. This may mean
As the noise
time for dispensaries to renegoa greater emphasis on preventive
subsides and
tiate a laboratory arrangement.
vision-care initiatives and a greater
the merger
On the frame side, it is likely
orientation toward medically based
progresses,
the same will happen, with
eye solutions, with products that
the dispensing
lesser-known brands sacrificing
address prevention and/or offer
ophthalmology
margins in order to hold or gain
cutting edge technology.
sector will need
> Increased direct-to-consumer admarket share during a time of
to look for
confusion.
vertising for the company brands:
guideposts as to
Someone once said, “NothCrizal, Varilux, LensCrafters, Eywhich direction
ing is ever as bad as it looks in
eMed, and perhaps the various
Essilor-Luxottica
the beginning and nothing is
frame brands.
TAKE-HOME
is heading.
POSSIBLE IMPLICATIONS
Current press releases from the proposed
partners indicate a “go slow” approach with
a window of 3 to 5 years for the complete
process to fully integrate.
What will be the implications for dispensing ophthalmology? At this point it is anyone’s guess.
HERE ARE SOME LIKELY SCENARIOS:
> Post-merger activity focused on reducing redundancies and lowering cost across all platforms
of the new business entity.
> Focus on revenue-enhancement opportunities.
That will most likely include learning how to leverage and sell to each other’s customers and the
sharing of resources to obtain new customers.
> Increased emphasis on growing and managing
its book of managed vision-care business, EyeMed.
Essentially, compete more aggressively with VSP.
> Find new and innovative ways to help independent eyecare providers be more successful and
more
online
G OI NG F ORWA R D
As the ballyhoo subsides and
the merger progresses, the dispensing ophthalmology sector will need to look for
guideposts as to which direction EssilorLuxottica is heading.
If this merger leads to greater inclusion
of ophthalmology’s desires to focus on delivery of medically based solutions, it will
mean a greater role for ophthalmology. On
the other hand, if the merger leads to greater
commoditization, the effect on ophthalmology would be negative. That could lead MDs
to move away from using Essilor and Luxottica products.
R E ACTIONS
In the short term, ophthalmology may find
that it is in an advantageous position. So
far this has proven true in the optical laboratory area, where the merger news has
ever as good as it looks in the
beginning.”
That is something to keep in
mind as the mega-merger moves forward.
Undoubtedly the ophthalmic landscape will
change over the next few years. That will
surely shape the way the newly forming
company will view its opportunities. ■
ARTHUR DE GENNARO is president of Arthur De Gennaro
& Associates LLC, an ophthalmic practice management firm that
specializes in optical dispensary issues. De Gennaro is the author
of the book The Dispensing Ophthalmologist. He can be reached at
803/359-7887, [email protected], or through the company’s Web site, www.
adegennaro.com. He maintains a blog at www.adgablog.wordpress.com.
ARON M. ARKON is a senior consultant with Arthur De Gennaro
& Associates LLC.
Neither author has a financial interest relevant to the subject matter.
The ‘art’ of the optical deal
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policy hurting business?
7 steps to boost optical revenue
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OPHTHALMOLOGYTIMES.COM/INVENTORY
APRIL 1, 2017 :: Ophthalmology Times
57
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APRIL 1, 2017 :: Ophthalmology Times
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marketplace
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(605) 328-6993 or (866) 312-3907 or email: [email protected]
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APRIL 1, 2017 :: Ophthalmology Times
60
marketplace
CAREERS
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technology
APRIL 1, 2017 :: Ophthalmology Times
61
Updated hand-held tonometer
enhances clinical experience
Refinements help operators align instrument even more accurately for more precise results
By Nancy Groves; Reviewed by Jane T. Shuman, MSM, COT, COE, OCS, CMSS, OSC
A
newly released hand-held tonometer model (Icare ic100,
Icare U.S.A.) features several
design upgrades while retaining the rebound technology for
measuring IOP that was at the
core of the earlier model.
“The rebound technology has proven to
be very good, so that’s one thing we did not
want to change,” said Holly Swain, OD, product manager, Icare U.S.A. “We added features
that should make IOP measurement even easier and more accurate.”
Responding to comments from customers, the
company focused on improving the interface
design and ergonomics of the tonometer. The
navigation system, with its improved menus
and large, color screen, makes the instrument
more user-friendly. The device has an automated
measuring sequence, which takes a series of six
measurements with a single touch of a button.
Other enhancements help operators align
the instrument even more accurately, which in
turn gives more precise results, Dr. Swain said.
For example, the tonometer has a built-in
intelligent position assistant that uses red and
green lights on the probe base to help users
place the instrument in the correct position.
In designing the device, the company also
upgraded features, such as the error codes.
Now, instead of displaying numerical codes
that users have to memorize, the instrument
gives a brief textual explanation, such as telling
operators they are too near or too far from the
patient. All of these changes help operators obtain consistent, repeatable, IOP measurements.
TAKE-HOME
An updated model of a hand-held
tonometer (Icare ic100, Icare U.S.A.),
relies on the same rebound measuring
technology as earlier instruments
but features enhancements to the
measuring, navigation, and positioning
systems.
“What I really like about [it] is a technician
can be very easily trained to use this device,
while still taking time to train them on the
Goldmann tonometer if that is what the practice requires,” said Jane T. Shuman, MSM, COT,
COE, OCS, CMSS, OSC, president of Eyetechs
Inc. In her role, she trains technicians and
evaluates practice efficiencies.
“The newer version lets users know they are
Continues on page 62 : Tonometer
Advertiser Index
Advertiser
Page
Advertiser
Page
Alcon Laboratories Inc. 25-26, 62, CV3, CV4
800/862-5266
www.alcon.com
OCuSOFT
800/233-5469
www.ocusoft.com
39
Bausch + Lomb
800/227-1427
www.bausch.com
Omeros Corp.
www.omeros.com
29
Ceatus Media Group
858/454-5505
www.ceatus.com
CV2, 15-16
27
Glaukos
800/452-8567
www.glaukos.com
Imprimis Pharmaceuticals
844/446-6979
www.imprimisrx.com
Johnson & Johnson Vision
(formerly AMO)
www.vision.abbott
7
11
CVTip, 5
Lightmed USA
www.lightmed.com
51
Marco Ophthalmic Inc.
800/874-5274
www.marco.com
37
NovaBay Pharmaceuticals
800/890-0329
www.avenova.com
13
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APRIL 1, 2017 :: Ophthalmology Times
62
technology
TONOMETER
( Continued from page 61 )
perfectly perpendicular to the cornea
and if they are too close or too far
from the eye, so they get perfect positioning on their own after they’ve
been shown how to use it,” she said.
The updated tonometer is suitable for all patients but should be
especially useful in helping practices
screen groups previously not seen
by technicians, such as pediatric
and corneal patients, Shuman said.
“Many corneal physicians want
to examine the virgin cornea before
the IOP is taken, but because the [device] doesn’t require any drops, it is
not going to affect the appearance of
the cornea,” she explained. “This
means the technician doesn’t have
to go back in to the patient after
the examination, and that the
physician doesn’t need to do it
him or herself.”
The tonometer also may be advantageous with immediate postoperative patients, since some corneal surgeons do not want the
cornea affected until after they’ve
examined it.
PEDIATRIC
PAT IE N T S
As for children, clinicians are
sometimes reluctant to measure
the IOP of their very young patients with the Goldmann tonometer because of the challenges of
correctly positioning them and
administering drops.
The rapidity of the measurement with the new instrument—
just a momentary contact with a
lightweight probe—and the dropless technique solve those issues.
The hand-held tonometer does
not require any drops and
therefore does not affect the
appearance of the cornea. The
updates to the system also has
improved usability with young
patients. (Photo courtesy of Icare U.S.A.)
Hand-held home monitoring
device approved by FDA
A PATIENT-ADMINISTERED DEVICE for home IOP monitoring (Icare Home,
Icare U.S.A.) has recently been granted premarket FDA approval for use in the
United States. The device will allow clinicians to track their patients’ IOP levels at
times during the day which they may not have otherwise had the ability to measure.
The device also provides the oppportunity to track and measure daytime spikes in
IOP. The device does not require topical drops or a puff of air, and is user-friendly
with its simple red-and-green, light-positioning system. The device received CE
approval in 2014 and is available in seven other countries.
“The original version of the tonometer was really pretty good,
but [the company] has certainly
made it more foolproof,” Shuman
said. “There are some physicians
who will only trust the Goldmann,
but for the general ophthalmologist this is a really good screening tool that can then be repeated
with the Goldmann if they find
something unexpected or have a
patient who is a glaucoma suspect
or diagnosed with glaucoma.” ■
JANE T. SHUMAN, MSM, COT, COE, OCS,
CMSS, OSC
E: [email protected]
Shuman is president of Eyetechs Inc.
HOLLY SWAIN, OD
E: [email protected]
Dr. Swain is product manager at Icare U.S.A.
ORA™ SYSTEM IMPORTANT PRODUCT INFORMATION
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
INTENDED USE: The ORA™ System uses wavefront aberrometry data in the measurement and analysis
of the refractive power of the eye (i.e. sphere, cylinder, and axis measurements) to support cataract
surgical procedures. CONTRAINDICATIONS: The ORA™ System is contraindicated for patients: who
have progressive retinal pathology such as diabetic retinopathy, macular degeneration, or any other
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irregularities resulting in higher order aberrations might yield inaccurate refractive measurements.
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Manual for a complete description of proper use and maintenance of the ORA™ System, as well as a
complete list of contraindications, warnings and precautions.
Advancing
CATARACT SURGERY
© 2015 Novartis 12/15 US-ORA-15-E-0947
The next advancement from the leader in intraoperative aberrometry
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• Provides IOL sphere, cylinder and alignment suggestions
Contact your local Alcon rep or
visit www.GuideandVerify.com for more information.
• Dynamic variable optimization and robust reporting powered by AnalyzOR™ Technology
See adjacent page for important product information.
ORA System
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© 2015 Novartis 12/15 US-ORA-15-E-0947
Advancing
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Bridging the gap to cataract refractive surgery.
© 2017 Novartis 3/17 US-CRS-16-E-1226(1)