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

PURPOSE: To identify recipient factors that may be related to risk of corneal graft failure.

DESIGN

Multicenter, prospective, double-masked, controlled clinical trial.

PARTICIPANTS

One thousand ninety subjects undergoing corneal transplantation for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic corneal edema).

METHODS

Donor corneas were assigned using a random approach without respect to recipient factors, 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 up for 5 years. Baseline factors were evaluated for their association with graft failure.

MAIN OUTCOME MEASURES: Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque to compromise vision for a minimum of 3 consecutive months.

RESULTS

Preoperative diagnosis of pseudophakic or aphakic corneal edema increased graft failure risk approximately 4-fold compared with Fuchs' dystrophy (27% vs. 7%). Prior glaucoma surgery with preoperative glaucoma medication use substantially increased the graft failure rate. Factors not strongly associated with graft failure included age, gender, diabetes, smoking, and graft size.

CONCLUSIONS

The risk of graft failure is significantly increased in eyes with pseudophakic or aphakic corneal edema compared with Fuchs' dystrophy, independent of lens status, and in eyes with a history of glaucoma.

FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.