1. Role of a Sutureless Amniotic Membrane Patch in Restoring the Corneal Surface Anterior Segment OCT Assessment Roxana Ursea, MD Matthew T. Feng, MD The authors have no financial interest in the subject matter of this poster

2. Sutureless Amniotic Membrane Patch *†  Superficial corneal erosion  Neurotrophic corneal epithelial defect/inflammation  Recalcitrant corneal inflammation  Acute chemical/thermal burns  ↑ Corneal epithelialization  ↓ Ocular surface inflammation  ↓ Pain † * AmnioGraft® (Bio-Tissue Inc, Miami, FL) † ProKera® (Bio-Tissue Inc, Miami, FL)  Acute Stevens-Johnson syndrome  Corneal transplant (to prevent high-risk complication/rejection)  Socket/fornix/lid reconstruction (to prevent lid/lash rubbing)  Severe bacterial keratitis

3. Purpose To evaluate the efficacy of sutureless, adhesiveless AM patch in the treatment of corneal thinning with and without epithelial defect using anterior segment optical coherence tomography (AS-OCT)

4. Methods  Retrospective noncomparative interventional case series  Setting: University of Arizona  Eight eyes (7 patients) received sutureless AM patch* from June 2007 to May 2009 for corneal thinning  With persistent epithelial defect (n = 4)  Without associated epithelial defect (n = 4)  Primary outcome measure: Minimum corneal thickness measured by AS-OCT †  Secondary outcomes:  Epithelial defect size, corneal surface, corneal clarity  Snellen BCVA, anterior segment inflammation  Pain, photophobia, side effects * ProKera® (Bio-Tissue Inc, Miami, FL) † Visante OCT® (Carl Zeiss Meditec, Dublin, CA)

5. Results * Pt. No. AgeSexEyeIndication(s)EtiologyPast Ocular History Prior Ocular Surface Treatment(s) Chronic Medications (Glaucoma) Corneal Clarity Epithelial Defect (mm) Defect Duration (m) 174FODT, PED Infectious keratitis, corneal abrasion Laser iridotomy, cataract AT, FML, Zaditor, abx Brimonidine, timolol Haze, inferior scar 1.3 x 1.56 275MOST, PEDPKP rejection Trauma, RD s/p PPV c/b PBK AT, Restasis, PF, abx Alphagan PHaze2.2 x 310 373FODT, PEDInfectious keratitis Cogan dystrophy, pseudophakia AT, abx, BCLNone Haze, subepithelial scar 0.7 x 0.75 459FOST, PEDInfectious keratitis RA, corneal melt s/p repair Fortified abxNoneHaze5.8 x 71.5 557FOSTRA Scleritis, dry eye, corneal endothelial dystrophy AT, Restasis, abx, Zaditor NoneClearNoneN/A 666FODT Sjogren, RA, scleroderma Dry eye, cataract Corneal scraping, PP, Restasis, AT, autologous serum tears, PF, abx NoneClearNoneN/A OST Corneal abrasion, dry eye, cataract Subepithelial scar NoneN/A 756FODTInfectious keratitisRuptured globe repair, dry eye, pseudophakia, trabeculectomy Muro, AT, Pred mild, Zaditor, abx Lumigan, Alphagan, Cosopt Haze, superior scar NoneN/A

6. AS-OCT: With Epithelial Defect Pt. 1 Pt. 2 Pt. 3 Before After

7. AS-OCT: No Epithelial Defect Pt. 5 Pt. 6 Pt. 7 Before After

8. Results Pt. No. Eye Epithelial Defect ProKera Duration (d) Objective Effect Duration (m) Subjective Follow- Up (m) Corneal Thickness (um) BCVA (Snellen) Conjunctival Inflammation Pain (0-10) Photophob ia PrePostPrePostPrePostPrePostPrePost 1OD+1637050020/10020/70 Trace injection, trace chemosis QuietOngoing80+-3.7 2OS+123805302/200 Quiet 200+-12 3OD+1046054020/30 Quiet Ongoing00++-1.3 4OS+20110360HM 1+ injection, trace chemosis QuietOngoing30+-2 5OS-646055020/2520/20Quiet Ongoing50+-15 6OD-1521040020/30020/200Quiet Ongoing30+++11.9 OS-222403603/20020/200Quiet Ongoing20+++11.1 7OD-1645050010/2008/200Trace injection Trace injection * Ongoing30--6

9. Corneal Thickness Over Time With PED No PED  After ProKera wear for a mean of 14.6 ± 5.2 days, corneal thickness increased 132 ± 64 μm by AS-OCT within one to four weeks of treatment in eyes with PED and within six weeks in those without defects  Duration of effect was at least 8.2 ± 5.3 months

10. Epithelial Defect Size Over Time Re-epithelialization occurred within one week in 75% of PED

11. Conclusions  After ProKera wear for a mean of 14.6 ± 5.2 days, corneal thickness increased 132 ± 64 μm by AS-OCT within 1 – 4 weeks of treatment in eyes with PED and within 6 weeks in those without defects  Duration of effect was at least 8.2 ± 5.3 months  Re-epithelialization occurred within one week in 75% of PED  Associated inflammation, pain and photophobia all decreased  ProKera is a convenient device that can easily be administered to manage corneal thinning and PED  AS-OCT was useful for quantifying ProKera’s clinical efficacy