Clinical Trial: Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant

Brief Summary: Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.

Detailed Summary:
Sponsor: Cornea Research Foundation of America

Current Primary Outcome: Endothelial Cell Loss [ Time Frame: 6 months after grafting ]

Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.


Original Primary Outcome: Endothelial Cell Loss [ Time Frame: 6 months after grafting ]

Current Secondary Outcome:

  • Best Corrected Vision [ Time Frame: 6 months and 1 year after grafting ]
  • Graft Dislocation [ Time Frame: 1 day to 1 month after grafting ]


Original Secondary Outcome: Same as current

Information By: Cornea Research Foundation of America

Dates:
Date Received: February 19, 2008
Date Started: January 2006
Date Completion:
Last Updated: March 28, 2016
Last Verified: October 2010