5/19/2016
Amniotic Membranes:
The New Frontier
COPE#48376-AS
Douglas K. Devries, O.D.
Walter O. Whitley, OD, MBA, FAAO
2016 Optometry’s Meeting
Boston, MA
Disclosures
• Douglas K. Devries
– Consultant or Speakers
Bureau for:
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Allergan
AMO
Alcon
Akorn
Bausch & Lomb/Valeant
BioTissue
Bruder
BVI
OcuSoft
RySurg
TearLab
Science Based Health
Shire Pharmaceuticals
• Walter O. Whitley
– Consultant or Speakers
Bureau for:
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Alcon
Allergan
Bausch & Lomb
BioTissue
BVI
Ocusoft
TearLab
Science Based Health
Shire
Advanced Recalcitrant PEK In Ocular
Surface Disease
• Autologous Serum
• Amniotic Membrane
Autologous Serum
• Contains
– Epithelial Growth Factor (EGF)
– Transforming Growth Factor 8 (TGF8)
– Fibronectin
– Vitamin A
– Other Cytokines
Autologous Serum
• Blood Draw at Lab
• Spin down to plasma @4000 rpm for 20
minutes
• Deliver to Compounding Pharmacy
• 2:1 Filtered Compounding with BSS
• 8 Bottles
• Frozen until used
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Autologous Serum
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1 gtt q2h from morning until bedtime
Keep Vial Refrigerated
Keep Additional Vials Frozen Until Use
8 Straight Weeks
Evaluate After 6-8 Weeks
Possible Additional Course
Autologous Serum Cost
• Lab Draw $30
• Compounding Pharmacy $120
• $150 for 8 Vials
– IF Patient delivers Serum to Pharmacy
Autologous Serum Cost
Lab Draw $30
Compounding Pharmacy $120
Virology Testing $210
Freeze and Shipment To/From Compounding
Pharmacy
• Approximately $450 to $550 for 8 Vials
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Sutureless Amniotic Membrane
• ProKera – Amniotic Membrane for wound
healing
– Cryopreserved
• Bio Optix
– Dehydrated Membrane
• IOP Ophthalmics
– Dehydrated Membrane
Biological Scaffolding
• Helps initiate an active healing process by
providing proteoglycans and growth factors
• Collagens, fibronectin and lamillin
• Cryopreserved membrane contains heavychain hyaluronic acid
• Inhibits proinflammatory cells
• Suppress T Cells
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Persistent Corneal Defect
Recurrent Cornea Erosion
Corneal Ulcer
Pterygium Graft
Bullous Keratopathy
Band Keratopathy
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Sutureless Amniotic Membrane
– Chemical Burns
– Mechanical Complications 2ary to graft
– Disruption of surgical wound
– Non-healing surgical wound
The Amniotic Membrane
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The amniotic membrane is the innermost lining of the
placenta (amnion)
Amniotic membrane shares the same cell origin as the fetus
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Structural similarity to all human tissue
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Technology Highlights
Impressive regenerative platform that
possesses natural growth factors and
optimal scaffolding properties within a
complex extracellular matrix that are:
• Anti-inflammatory
• Anti-scarring
• Anti-angiogenic
Therapeutic actions:
• Promotes Stem Cell Expansion
• Suppresses pain
• Promotes cellular migration
• Expedites recovery
Inflammation is the Hallmark of
All Ocular Surface Diseases
Ocular Surface
Disease
Stem cell behavior
Corneal
Inflammation
Conjunctival
Inflammation
Keratitis
I
Inflammation’s
Effect on
H
Healing
Conjunctivitis
Blepharitis
Diabetic Foot Ulcer
DIAGNOSIS & PATIENT HISTORY
NEOX® TREATMENT & OUTCOME
Patient suffering from a chronic diabetic wound open
for 5 years; failed serial debridement, wound vacs,
and allografts. Now the patient has formed a
contralateral ulcer.
Patient brought to the OR for sharp debridement
and first NEOX® application. Second and third
NEOX® applications placed in the first 4 weeks with
both wounds nearly healed to date (10 weeks).
ƒ Inflammation:
I fl
ti
the
th first sign of wound healing & is also the
hallmark symptom of all ocular surface diseases
ƒ Uncontrolled inflammation leads to:
ƒ Chronic pain and discomfort/irritation
ƒ Delayed healing, more tissue damage
ƒ Vision-threatening complication, e.g., scar/haze
ƒ Effective control of inflammation is an important strategy to
promote healing and minimize the risk of scar/haze
Non-Resolved
Inflammation
Eyelid
Inflammation
1.0 cm width X 2.0 cm
length x 5 mm depth
Debridement
4 WEEKS
After Cryopreserved Umbilical
Cord #1 & #2
Tissue Damage
Controlling Inflammation is Key to Preventing Tissue Damage!
Umbilical Cord #3
10 WEEKS
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Chemical Burn
Patient Presents 8 Days
after Chemical Burn
Complete Epithelium
Damage
PROKERA® is placed
on first day of treatment
Day 3
Day 10
Day 12
Day 15
Day 17
Day 5
Day 17
Limbal Stem Cell
Expansion Begins
Day 7
Limbal Stem Cell
Expansion Continues
Difference Between Dehydrated and
Cryoperserved Amniotic Tissue
Complete Scarless
Healing
Scarless Fetal Wound Healing
HC-HA/PTX3 Orchestrates the
Regenerative Healing Process
Speed & Quality of Healing Count!
By Modulating the Innate and Adaptive Immune Response
HC-HA
HC-HA
Giant neck mass resection at
26 weeks in-utero
Facilitates Neutrophil
Apoptosis (Cell Death)
HC-HA
Changes M1 Inflammatory
Macrophages to M2 AntiInflammatory Macrophages
3 months
HC-HA
HC-HA
HC-HA
HC-HA
HC-HA
Suppresses Th1 & Th17
Lymphocyte Activation
HC-HA/PTX3, found naturally in
amniotic membrane, is the critical
biologic component responsible for
scarless fetal wound healing.
Promotes Regenerative
Healing
Courtesy of fetal surgeon, Michael Harrison, M.D. (UCSF)
٫ CRYOTEK® cryopreservation
method allows us to preserve AM
at -80ºC without forming ice
(minimal manipulation from fresh
AM). Thus, our products:
1. Maintain the structural and
biological integrity of the
membrane
2. Retain meaningful quantities
of HC-HA/PTX3 to activate
regenerative healing
3. Retain the original tensile
strength of AM, facilitating
ease of handling during
surgery
ƒ PROKERA® utilizes the proprietary
CryoTek™ cryopreservation process
that maintains the active
extracellular matrix of the amniotic
membrane which uniquely allows for
regenerative healing.
The processing method is the key to retaining potency.
ƒ PROKERA® is the only FDA-cleared
therapeutic device that both reduces
inflammation and promotes scar less
healing
ƒ PROKERA® can be used for a wide
number of ocular surface diseases
with severity ranging from mild,
moderate, to severe
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Contraindications
• Not to be used with
patients with glaucoma
filters
• Allergies to
Ciprofloxacin or
Amphotericin B
Insertion of Cryopreserved Amniotic
Tissue
• Open package exposing contained Membrane
• Rinse with saline liberally (prevents stinging
from preservation media
• Apply topical anesthesia
• Hold upper lid and have patient look down
• Insert into superior fornix
• Slide under lower eyelid
• Check for centration
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Post-Treatment Protocol
Continue
medications
Possible Tape Tarsorrhaphy
Apply Temporary
Tarsorrhaphy (PRN)
- Tape
- Tegaderm
- “Breathe-Right”
nasal strips
CONFIDENTIAL AND PRIVILEGED Property of Bio-Tissue, Inc.
Do not reproduce or distribute.
PROKERA® Removal
Dehydrated Amniotic Membrane
• Topical Anesthetic
• Pull the lower eyelid
• Lift the lower edge of
PROKERA® using a Q-tip or
forceps
• Ask the patient to look down
• Slide the PROKERA® out with
gentle pressure on the upper
eyelid
CONFIDENTIAL AND PRIVILEGED Property of
Bio-Tissue, Inc. Do not reproduce or
distribute.
Dehydrated Amniotic Membrane
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Self Retaining Amniotic Membrane
• Cost of Pro Kera Approximately $900 to $1000
• Cost of Bio Optix Approximately $600
• Medicare Allowable Nevada $1520
Self Retaining Amniotic Membrane
• CPT 65778 Bundled with supply
• V2790 supple code for non CMS
Conjunctival Chalasis (CCH)
• Breakdown of Tenons Capsule
• MMP 9
• Fibro vascular gel like tissue
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Definition of Reservoir Restoration Procedure (n): A simple, surgical procedure
for Conjunctivochalasis Dry Eye that restores the function of the anatomical tear
reservoir (fornix) by:
1) Removing deteriorated Tenon’s Capsule
2) Rearranging or removing loose conjunctiva
3) Deepening the fornix, and
4) Using cryopreserved amniotic membrane to replace the Tenon’s and
conjunctiva, to help prevent recurrence, and to expedite a patient’s
recovery
Reservoir Restoration
Procedure
After Reservoir Restoration
Conjunctivochalasis
CCh Also Obstructs the Tear Meniscus and
Blocks Tear Clearance
Go to the Source:
Hydrodynamics (Water Movement) that Hydrates the Ocular Surface
CCh interferes with the tear meniscus
1
FORNIX
2
MENISCUS
3
OCULAR
SURFACE
Meller & Tseng. Surv Ophthalmol. 1998;43:225–232
Gumus et al. AJO. 2010; 150:798-806
CCh blocks tear flow into the
punctum to cause delayed tear
clearance
2
Liu D. Ophthalmol Plast Reconst Surg. 1986;2:25–28
Maskin. Cornea. 2008;27:644-649.
Why not just cut it off or cauterize it?
Scar Formation, Fat Prolapse, and not Correcting the Fornix
3
1
Reservoir
ese o Restoration
esto at o u
using
s g AmnioGraft®
oG a t®
PRE OP
5 YEARS POST OP
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CCh Paradox:
Why are some CCh patients asymptomatic?
Normal
CCh without Symptoms CCh with Symptoms
CCh after AMT
Original
height
0 sec
3 sec
Successful Implementation
• Use CCh Reference Card,
Dry Eye Dry Erase Board,
and CCh Animation Video to
demonstrate to your patients
how CCh can cause dry eye
8 sec
Blinking helps ATD dry eye, but not
CCh dry eye
Di Pascuale
P
et al. BJO. 2004;88:388–392
• Use metaphors to explain the
tear meniscus and tear
reservoir concept
– Tip of the Iceberg
– Wrinkled fabric
Afternoon Workshop
• Overview of AM
• Case studies / reports
• Wet lab
Douglas K. Devries, O.D.
Eye Care Associates of Nevada
[email protected]
Walter O. Whitley, OD, MBA, FAAO
Virginia Eye Consultants
[email protected]
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