8/11/2017. Rob Allen, O.D. Rob Allen, Ph.D. Rob Allen, O.D. None. Rob Allen, Ph.D. Represents BioD/BioDOPTIX Amniotic Membrane

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1 Rob Allen, O.D. Rob Allen, Ph.D. VisionAmerica August 25, 2017 Rob Allen, O.D. None Rob Allen, Ph.D. Represents BioD/BioDOPTIX Amniotic Membrane Rob Allen, O.D. Rob Allen, Ph.D. 1

2 Rob Allen, O.D. Rob Allen, Ph.D. Creepy! Rob Allen, O.D. Rob Allen, Ph.D. Sleepy Creepy! Rob Allen, O.D. Rob Allen, Ph.D. 2

3 O.D., B.S. Pennsylvania College of Optometry B.A. University of Richmond, Virginia Fellow Virginia Academy of Optometry ABO Active Candidate January 2018 exam Managing Partner - Ashburn Eyecare Associates - Associates in Eyecare, P.C. Past-President - Virginia Optometric Association Past-President - Northern VA Optometric Society O.D. of the Year - Virginia Optometric Association Vanguard Award - Virginia Optometric Association Clinical Investigator - Miravant Advisory Board - TLC The Laser Center Advisory Board - Bausch & Lomb Board of Directors - Oatlands Plantation, Leesburg, VA Board of Directors - Cycle Aviation Commercial/Instrument/Multi-Engine Rated Pilot 3

4 Ph.D. - Harvard University (magna cum laude) M.A. - Kellogg College - Oxford, England B.S. - Union University (magna cum laude) Jackson, TN Co-Founder Ocular Ventures VC Group Business Development Leader BioD, LLC/Integra LifeSciences Dad Research: - Proprietary studies developing regenerative medicine products from placental birth tissues (10+ years) - IRB driven studies denoting the uses of amniotic tissue across multiple specialties Military Service: - CDR, U.S. Navy (20+ years service Active/Reserves) - NSW SEAL Team FIVE (Active) - NSW Reserve Seal Team 17 (Reserves) Medals/Honors: - Bronze Star - Purple Heart - Navy/Marine Corps Commendation - Navy/Marine Corps Service Medal Rob Allen, O.D. Clinician who sees a lot of KCS, abrasions, erosions, etc. Rob Allen, Ph.D. Ph.D. in molecular and cellular biology Clinical research Hey I know the science and I can teach it! What??? More stuff to learn how to do??? 4

5 Let s Talk About: Placental Birth Tissues What is the Amnion? Amniotic Tissue Derivation Composition of Amniotic Membrane - First Used in Dermatology in Skin graft - Transplantation - Natural bandage - Found to aid in wound healing - First Known Ophthalmological Use DeRoth used on conjunctival defects - Sorsby & Symons Treated chemical burns - Juan F. Batlle, M.D. (1992) - Presented cases at the 1993 American Academy of Ophthalmology meeting in Chicago - Treatment of dermoids - Pterygium - Fornix reconstruction - Alkali burns - Bullous keratopathy Current Applications: - Wound Care 5

6 Orthopedic and Spine Care/Rehabilitation Dental Ocular (that s what we REALLY want to hear about, right?): Signals Cells Structure 6

7 Signals Protein Rich Environment Growth Factors Enzymes Cytokines Lock & Key Communication Structure Extracellular Matrix Physical Barrier Protective Wound Covering Cells Limbal Cells Engaged in Healing Process Second Wave of Cellular Regeneration Adult Healing vs Regenerative Healing Promotes Angiogenesis Anti-angiogenic Anti-viral Anti-scarring Anti-bacterial Scar Tissue - Promotes Epithelialization/Re-Epithelialization - Works to Reduce/Eliminate Inflammation - Anti-Scarring Activity - Analgesic Properties - Anti-Angiogenic Properties - Neurotrophic Factors - Anti-Microbial Properties - Protection Against Loss of Fluids and Proteins 7

8 Two types: 1. Cryopreserved 2. Dehydrated How Can You Tell Them Apart? Very Easy 8

9 1) Cryopreserved PROKERA (Biotissue) - Class II FDA Cleared Ocular Conformer - Approved by the FDA in Polycarbonate Ring Houses Amniograft PROKERA After Instillation on Eye 2) Dehydrated: BioDOPTIX (Integra Life Sciences/BioD, LLC) AmbioDisk (IOP Ophthalmics/Katena) Aril (SeedBiotech) SteriShield II (Bone Bank Allografts) 9

10 Dehydrated Sutureless Amniotic Membrane (during instillation) Neurotrophic Corneal Epithelial Defects Shield Ulcers Corneal Abrasions Corneal Ulcers Chemical/Thermal-Induced Corneal Burns Microbial Keratitis Keratoconjunctivitis Sicca and Exposure Keratopathy Recurrent Corneal Erosion and Corneal Dystrophies Salzmann s Nodular Degeneration Post-infectious Herpes Keratitis Limbal Stem Cell Deficiency Pterygia This is NOT a guarantee of coverage or payment. Always consult LCD Neurotrophic Corneal Epithelial Defect 10

11 Shield Corneal Ulcer Corneal Ulcer Corneal Abrasion Acute Alkali (chemical) Burn 11

12 Acute Thermal Burn Microbial Keratitis Keratoconjunctivitis Sicca (KCS) Exposure Keratopathy 12

13 Recurrent Corneal Erosion Corneal Dystrophy (EBMD) Salzmann Nodular Degeneration 13

14 Herpes Keratitis (DO NOT USE SUTURELESS AMNIOTIC MEMBRANE AT THIS STAGE) Limbal Stem Cell Deficiency Pterygium 14

15 Why Wouldn t you Want to Provide an Effective Additional Treatment Option? Want to Separate Yourself From Other Practitioners? Want to Use a Relatively New and Available Treatment Option? Sutureless Amniotic Membrane Is: Indicated Easy to Use in Office Cost Effective/NOT Cost Prohibitive Readily Available I don t see those kinds of patients What?? Do you see patients? Amniotic membrane is WAY too expensive You may be very surprised But the old way of treating my patients works a lot of the time So you don t want to use a proven method that works well? Reimbursements will soon be cut Uhhhhhhh. I don t want an insurance audit Document, Document, Document! 15

16 Wet Lab: Overview of Application Techniques - Video demonstration BioDOptix Packaging: - Graft Size - Lot Number - Expiration Date - Tracking Information - Inside The Box - Product Insert - Tracking Record - Why? - What info needed? - What info not needed? - What if not mailed back? - Dual Packaging (what you see) - Red dot - Blue mesh - Membrane - Stromal Side - Epithelial Side Outer Pouch / Aluminum Packaging Inner Pouch - Tyvek 16

17 Tools - Wexcel sponge - Forceps - Speculum (optional) Tissue forceps Speculum Types of Forceps: - Rubber tip - Pointed tip / tweezers - Tissue forceps (see picture) - Debakey forceps - Cheap tweezers from Kroger Wexcel sponge Room Preparation (lay out what you need) - Forceps - Numbing agent - Speared Sponge (Weck-cel) - Speculum (optional) - Antibiotic drops (optional) - Membrane Patient Preparation - SIGN CONSENT FORM - Patient position (supine or sitting) Doctor Preparation - Gloves (optional) - BCL determination 17

18 Procedure - Ready?? Here we go - Numbing agent - Preparation of cornea - Placement of speculum (optional) - Dry ocular surface - Remove membrane from packaging - Place membrane on ocular surface - Rehydration vs adherence - Place bandage contact lens - Instill antibiotic drops (optional) - Verify placement of membrane through slit-lamp examination Procedure - Ready?? Here we go - Numbing agent - Preparation of cornea - Placement of speculum (optional) - Dry ocular surface - Remove membrane from packaging - Place membrane on ocular surface - Rehydration vs adherence - Place bandage contact lens - Instill antibiotic drops (optional) - Verify placement of membrane through slit-lamp examination 5 D s: Deaden it Dab it Decide it Do it Drape it Procedure - Ready?? Here we go - Numbing agent - Preparation of cornea - Placement of speculum (optional) - Dry ocular surface - Remove membrane from packaging - Place membrane on ocular surface - Rehydration vs adherence - Place bandage contact lens - Instill antibiotic drops (optional) - Verify placement of membrane through slit-lamp examination Post Procedure Instructions / Patient Education - Common patient complaints / comments - PROKERA - Dehydrated membrane (all others) - Care of eye post procedure 18

19 - Follow-up Care - Helpful Hints - Hands-on Demonstration - Glass eye - Pig eye - Human eye - See one - Do one - Teach one 19

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