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Rose K. Sia, Kraig S. Bower, Charles D. Coe, Denise S. Ryan, Lamarr Peppers, Jennifer B. Eaddy, Shachar Tauber, Scheffer C. Tseng; One year Visual Outcomes in Sutureless Cryopreserved Amniotic Membrane Graft (ProKeraTM) After Photorefractive Keratectomy (PRK). Invest. Ophthalmol. Vis. Sci. 2011;52(14):5744.
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To evaluate the effect of ProKera on corneal wound healing after PRK in terms of refractive efficacy, safety, accuracy and stability.
This was a prospective, open-label, non-randomized, control trial of 40 subjects undergoing PRK at the Walter Reed Center for Refractive Surgery. A 9.0mm epithelial defect was created using 20% ethanol solution followed by photoablation with Wavelight ALLEGRETO WAVE Eye-Q 400 MHz laser platform (Wavelight AG, Erlangen, Germany). After surgery, a high oxygen transmissible bandage contact lens (BCL) was placed on the dominant eye and a sutureless, cryopreserved Amniotic Membrane (ProKeraTM) was applied on the fellow non-dominant eye in place of the BCL. Postoperative regimen for both eyes was identical. Daily follow up was done until complete reepithelialization (RE) was documented in both eyes. Clinical outcomes were evaluated at 1, 3, 6 and 12 months (M) post op.
There was no significant difference between ProKera vs. BCL in achieving uncorrected visual acuity (UCVA) of 20/20 or better at 1M (89.7% vs. 87.2%), 3M (100.0% vs. 100.0%), 6M (97.4% vs. 97.4%) and 12M (97.1% vs. 100.0%) [p=0.99]. One ProKera eye lost 2 best-corrected visual acuity (BCVA) lines at 1M due to delayed RE. BCVA was otherwise maintained within ±1 line change from preop in both groups at 3, 6, and 12M. There was no significant difference between ProKera vs. BCL in manifest spherical equivalent (MSE) within ±0.50 diopters (D) of emmetropia at 1M (84.6% vs. 84.5%), 3M (97.3% vs. 88.8%), 6M (100.0% vs. 92.3%) and 12M (88.6% vs. 88.6%) [p=0.99, 0.36. 0.24 and 0.99, respectively]. Between the 3M to 12M interval, 81.2% ProKera vs. 90.6% BCL eyes had <0.50D change in manifest refraction [p=0.47].
Visual outcomes after using ProKera to promote corneal RE in PRK were comparable to the outcomes after standard BCL use.
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