CORNEAL DONOR STUDY

Jaeb Center For Health Research, Inc., Tampa FL

Investigators

Linked publications & trials

Abstract

Several emerging problem areas in corneal transplantation and organ donation are likely to reduce the availability of corneal donor tissues in the United States. Such a reduction would significantly jeopardize the visual health of thousands of Americans who currently depend upon the eye banking system to provide safe and effective corneal tissue for sight restoration on a timely basis. The most easily implemented solution is to increase utilization of older donor-age tissue which is currently discarded or not even collected. Although a definitive study has not been performed, the weight of current evidence suggests that donor age is not an important predictor of graft failure when other criteria for suitability of the donor tissue (e.g., endothelial cell count) are met. Unfortunately, a strong bias exists against use of older donor tissue by many corneal surgeons and eye banks. Many surgeons and eye banks have arbitrarily set an upper age limit for the use of corneal tissue. Therefore, a considerable amount of potentially usable donor tissue is either not being harvested or, if harvested, goes unused because of this bias. To provide these much needed data, the Corneal Donor Study (CDS) was developed. The specific objective of the study is to determine whether the graft-failure rate over a 5-year follow-up period is equivalent with corneal tissue from donors older than 60 years old compared with that from younger donors. The study protocol is summarized below. Exposure Variable: Age of donor tissue. Sample Size: 1000 patients with approximately half receiving tissue from donors > 60 and half from donors <60 Outcome Measure: Graft failure or regarding from a 5-year follow-up period Recipient Eligibility Criteria: (1) Age range: 40-80 years, (2) Corneal disease. Presence of a condition associated with endothelial dysfunction, including pseudophakic corneal edema, Fuchs' dystrophy, posterior polymorphous dystrophy, irido-corneal-endothelial (ICE) syndrome, endothelial failure, interstitial keratitis (non-herpetic), or perforating corneal injury. Donor Eligibility Criteria: (1) Endothelial cell count> 2000 by specular microscopy according to the Eye Bank's usual routine, (2) Death to preservation time <15 hours if body or eyes refrigerated and <6 hours if not refrigerated, (3) Death to surgery time <7 days, (4) Age 10-79, (5) Phakic.