April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
One year Visual Outcomes in Sutureless Cryopreserved Amniotic Membrane Graft (ProKeraTM) After Photorefractive Keratectomy (PRK)
Rose K. Sia; Kraig S. Bower; Charles D. Coe; Denise S. Ryan; Lamarr Peppers; Jennifer B. Eaddy; Shachar Tauber; Scheffer C. Tseng
Author Affiliations & Notes
  • Rose K. Sia
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, Dist. of Columbia
  • Kraig S. Bower
    The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland
  • Charles D. Coe
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, Dist. of Columbia
  • Denise S. Ryan
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, Dist. of Columbia
  • Lamarr Peppers
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, Dist. of Columbia
  • Jennifer B. Eaddy
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington, Dist. of Columbia
  • Shachar Tauber
    Department of Ophthalmology, St. John's Hospital and Clinics, Springfield, Missouri
  • Scheffer C. Tseng
    Ocular Surface Center, Ocular Surface Res & Educ Fndtn, Miami, Florida
  • Footnotes
    Commercial Relationships  Rose K. Sia, None; Kraig S. Bower, None; Charles D. Coe, None; Denise S. Ryan, None; Lamarr Peppers, None; Jennifer B. Eaddy, None; Shachar Tauber, None; Scheffer C. Tseng, 10/472, 117 (P), TissueTech Inc. (E, C), TissueTech, Inc. (I)
  • Footnotes
    Support  NIH, NEI, EY014768
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 5744. doi:
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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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Abstract

Purpose: : To evaluate the effect of ProKera on corneal wound healing after PRK in terms of refractive efficacy, safety, accuracy and stability.

Methods: : 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.

Results: : 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].

Conclusions: : Visual outcomes after using ProKera to promote corneal RE in PRK were comparable to the outcomes after standard BCL use.

Clinical Trial: : http://www.clinicaltrials.gov NCT00915759

Keywords: refractive surgery: PRK • refractive surgery: other technologies • refractive surgery: optical quality 
© 2011, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. Permission to republish any abstract or part of an abstract in any form must be obtained in writing from the ARVO Office prior to publication.
Copyright © 2024 Association for Research in Vision and Ophthalmology.
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