Factors Associated With Corneal Graft Survival in the Cornea Donor Study

Importance The Cornea Donor Study (CDS) showed that donor age is not a factor in survival of most penetrating keratoplasties for endothelial disease. Secondary analyses confirm the importance of surgical indication and presence of glaucoma in outcomes at 10 years. Objective To assess the relationship between donor and recipient factors and corneal graft survival in the CDS. Design, Setting, and Participants Multicenter prospective, double-masked, controlled clinical trial conducted at 80 clinical sites. One hundred five surgeons enrolled 1090 participants undergoing corneal transplant for a moderate-risk condition, principally Fuchs dystrophy or pseudophakic or aphakic corneal edema (PACE). Forty-three eye banks provided corneas. Interventions Corneas from donors younger than 66 years and donors 66 years or older were assigned, masked to donor age. Surgery and postoperative care were performed according to the surgeons’ usual routines. Participants were followed up for as long as 12 years. Main Outcomes and Measures Graft failure, defined as a regrafting procedure or a cloudy cornea for 3 consecutive months. Results The 10-year cumulative probability of graft failure was higher in participants with PACE than in those with Fuchs dystrophy (37% vs 20%; hazard ratio [HR], 2.1 [99% CI, 1.4-3.0]; P P P  = .04) or were African American (HR, 1.5; P  = .11) or who had a history of smoking (35% vs 24%; HR, 1.6 [99% CI, 0.9-2.8]; P  = .02). Lower endothelial cell density (ECD) and higher corneal thickness (CT) at 6 months (6% vs 41% for ECD ≥2700 vs 2 [ P P  = .001]), 1 year (4% vs 39% for ECD ≥2700 vs 2 [ P P  = .04]), and 5 years (2% vs 29% for ECD ≥1500 vs 2 [ P P Conclusions and Relevance Most penetrating corneal grafts for Fuchs dystrophy or PACE remain clear at 10 years. The risk for failure is greater for graft recipients with PACE and those with a history of glaucoma. Measurements of ECD and CT during the course of postkeratoplasty follow-up are associated with a risk for failure. However, even with very low ECD and high CT at 5 years, most corneas remain clear at 10 years.