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.
To assess the relationship between donor and recipient factors and corneal graft survival in the CDS.
Multi-center prospective, double-masked, controlled clinical trial
105 surgeons from eighty clinical sites enrolled participants and forty-three eye banks provided corneas.
1090 subjects undergoing corneal transplantation for a moderate risk condition, principally Fuchs’ dystrophy or pseudophakic/aphakic corneal edema (PACE)
Intervention(s) for Clinical Trials or Exposure(s) for observational studies
Corneas from donors <66 years or ≥ 66 years were assigned, double-masked to donor age. Surgery and post-operative care were performed according to surgeons’ usual routines. Subjects were followed for up to twelve years.
Main Outcome Measure(s)
Graft failure defined as a regraft or a cloudy cornea for 3 consecutive months.
The 10-year graft failure rate was higher in cases with PACE than with Fuchs’ dystrophy (37% versus 20%, p < 0.001) and in cases with a history of glaucoma prior to penetrating keratoplasty, particularly with prior glaucoma surgery (58% with prior glaucoma surgery and medications at time of surgery versus 22% with no history of glaucoma, p<0.001). There were trends towards increased graft failure in recipients who were older (p=0.04), African-American (p=0.11), or had a smoking history (p=0.02). Lower endothelial cell density (ECD) and higher corneal thickness (CT) at 6 months, 1 year, and 5 years were associated with subsequent graft failure (p=0.04 to <0.001).
Conclusions and Relevance
Most penetrating corneal grafts for Fuchs’ dystrophy or PACE remain clear at 10 years. The risk of failure is greater for those with PACE and when there is a history of glaucoma. ECD and CT measurements during the course of post-keratoplasty follow up are associated with risk of failure. However, even with very low ECD and high CT at 5 years, most corneas remain clear at 10 years.