The Cornea Donor Study was designed to investigate the safety and efficacy of older donor corneal tissue compared with younger donor tissue in recipient eyes at moderate risk to the graft from progressive endothelial failure. Baseline patient data, including indications for transplant, intraoperative complication rates, and early postoperative complication rates are described herein.
This study was a multicenter prospective, double-masked, controlled clinical trial.
Fuchs dystrophy was the most common indication for corneal transplantation (61%). Intraoperative complications occurred in 33 (3%) patients. A persistent epithelial defect was the most commonly reported postoperative complication, occurring in 92 patients (8%).
Intraoperative and postoperative complication rates were low. There was no apparent association between donor or recipient age and either intraoperative or early postoperative complication rates.
Received for publication September 15, 2004; accepted March 9, 2005.
Supported by a cooperative agreement from the National Eye Institute, National Institutes of Health, U10 EY12358. Additional support provided by Eye Bank Association of America, The Cornea Society, Tissue Banks International, Vision Share, Inc., Bausch & Lomb, Katena Products, Inc., Konan Medical Corp., ViroMed Laboratories, Inc., Eye Bank for Sight Restoration, Lions Eye Bank of Oregon, Midwest Eye-Banks and Transplantation Center (Michigan Eye Bank, Illinois Eye Bank), Northwest Lions Eye Bank, San Diego Eye Bank, and Sight Society of Northeastern New York (Lions Eye Bank of Albany).
*A list of the writing committee, clinical site investigators, and coordinators and eye bank staff who participated in the study appears in the Appendix.
Reprints: Mark J. Mannis, MD, c/o Cornea Donor Study Coordinating Center, Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647 (e-mail: firstname.lastname@example.org).