April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Sutureless Cryopreserved Amniotic Membrane Graft (ProKeraTM) vs. Bandage Contact Lens (BCL): Comparing Optical Quality of the Cornea After Photorefractive Keratectomy (PRK)
Author Affiliations & Notes
  • Denise S. Ryan
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington DC, 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 DC, Dist. of Columbia
  • Rose K. Sia
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington DC, Dist. of Columbia
  • Lamarr Peppers
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington DC, Dist. of Columbia
  • Richard D. Stutzman
    Center for Refractive Surgery, Walter Reed Army Medical Center, Washington DC, 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  Denise S. Ryan, None; Kraig S. Bower, None; Charles D. Coe, None; Rose K. Sia, None; Lamarr Peppers, None; Richard D. Stutzman, None; Shachar Tauber, None; Scheffer C. Tseng, 10/472,117 (P), TissueTech, Inc. (I, E, C)
  • Footnotes
    Support  NIH, NEI, EY014768
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 5741. doi:
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      Denise S. Ryan, Kraig S. Bower, Charles D. Coe, Rose K. Sia, Lamarr Peppers, Richard D. Stutzman, Shachar Tauber, Scheffer C. Tseng; Sutureless Cryopreserved Amniotic Membrane Graft (ProKeraTM) vs. Bandage Contact Lens (BCL): Comparing Optical Quality of the Cornea After Photorefractive Keratectomy (PRK). Invest. Ophthalmol. Vis. Sci. 2011;52(14):5741.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose:
 

To compare optical quality of ProKera vs. BCL after PRK in terms of corneal surface regularity and corneal haze.

 
Methods:
 

Forty subjects undergoing PRK at the Walter Reed Center for Refractive Surgery were enrolled in a prospective, open-label, non-randomized, controlled trial. Standard 9.0 mm epithelial defects were created using a 20% ethanol solution followed by photoablation using the ALLEGRETO WAVE Eye-Q 400 MHz laser platform (Wavelight AG, Erlangen, Germany). ProKera was applied on the non-dominant eye after surgery and a high oxygen transmissible BCL on the dominant eye. The following TMS-4 corneal topography (Tomey, Phoenix, AZ) indices were used to assess optical quality: surface asymmetry index (SAI), surface regularity index (SRI), and irregular astigmatism index (IAI). Corneal haze was also assessed at 1 week (W), 2W, 1, 3, 6, and 12 months (M) postoperatively. A Wilcoxon signed ranks test was used to compare ProKera to BCL and a P value <0.007 was considered significant, adjusting for multiple comparisons across 7 time points.

 
Results:
 

Median topography indices of ProKera vs. BCL are listed on Table 1. There was no significant difference between ProKera vs. BCL in measures of SRI or IAI. There was a significant difference in SAI at 1 month between ProKera and BCL, but not at any other time point. At 1M, 9 more ProKera eyes had haze than BCL eyes (P=0.002). The difference in corneal haze was not significant at other visits 1W(P= 0.99), 2W(P=0.99), 3M(P=0.25), 6M(P=0.25), 12M(P=0.50).

 
Conclusions:
 

ProKera was comparable to BCL when investigating corneal clarity and quality of vision. The role of ProKera in modulating wound healing after PRK remains speculative.  

 
Clinical Trial:
 

http://www.clinicaltrials.gov NCT00915759

 
Keywords: refractive surgery: PRK • refractive surgery: optical quality • refractive surgery: other technologies 
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