Donor risk factors for graft failure in the cornea donor study.

PURPOSE The purpose of this study was to assess the relationship between donor factors and 5-year corneal graft survival in the Cornea Donor Study. METHODS Donor corneas met criteria established by the Eye Bank Association of America, had an endothelial cell density of 2300 to 3300/mm, and were determined to be of good to excellent quality by the eye banks. Donor corneas were assigned using a random approach and surgeons were masked to information about the donor cornea including donor age. Surgery and postoperative care were performed according to the surgeons' usual routines and subjects were followed for 5 years. Donor and donor cornea factors were evaluated for their association with graft failure, which was defined as a regraft or a cloudy cornea that was sufficiently opaque to compromise vision for a minimum of 3 consecutive months. RESULTS Graft failure was not significantly associated with the type of tissue retrieval (enucleation versus in situ), processing factors, timing of use of the cornea, or characteristics of the donor or the donor cornea. Adjusting for donor age did not affect the results. CONCLUSION Donor and donor cornea characteristics do not impact graft survival rates for corneas comparable in quality to those used in this study.