Objective-To determine whether endothelial cell loss 5 years after successful corneal transplantation is related to the age of the donor.
Design-Multicenter, prospective, double-masked clinical trial.Participants-Three hundred forty-seven subjects participating in the Cornea Donor Study who had not experienced graft failure 5 years after corneal transplantation for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic corneal edema).Testing-Specular microscopic images of donor corneas obtained before surgery and postoperatively at 6 months, 12 months, and then annually through 5 years were submitted to a central reading center to measure endothelial cell density (ECD).
Main Outcome Measure-Endothelial cell density at 5 years.Results-At 5 years, there was a substantial decrease in ECD from baseline for all donor ages. Subjects who received a cornea from a donor 12 to 65 years old experienced a median cell loss of 69% in the study eye, resulting in a 5-year median ECD of 824 cells/mm 2 (interquartile range, 613-1342), whereas subjects who received a cornea from a donor 66 to 75 years old experienced a cell loss of 75%, resulting in a median 5-year ECD of 654 cells/mm 2 (interquartile range, 538-986) (P [adjusted for baseline ECD] = 0.04). Statistically, there was a weak negative association between ECD and donor age analyzed as a continuous variable (r [adjusted for baseline ECD] = −0.19; 95% confidence interval, −0.29 to −0.08).Conclusions-Endothelial cell loss is substantial in the 5 years after corneal transplantation. There is a slight association between cell loss and donor age. This finding emphasizes the importance of longer-term follow-up of this cohort to determine if this relationship affects graft survival.Corneal clarity after penetrating keratoplasty can be affected by endothelial cell loss over time. The exact cause of postoperative cell loss is unknown but may be a result of donor or preservation factors, surgical stress, cellular interactions between the donor and recipient, immune reaction, normal or accelerated cellular aging, or glaucoma. The Eye Bank Association of America requires endothelial cell density (ECD) determination via specular microscopy as a standard corneal tissue evaluation method but does not require a minimum cell density for transplant suitability. 1 Clinicians typically prefer donor corneas with a high pre-operative ECD in order to offset posttransplant cell loss under the belief that this will improve the probability of graft survival. Past studies evaluating endothelial cell loss after corneal transplantation have produced conflicting results with regard to the effect of donor age. Some studies suggest that there is no difference in endothelial cell loss comparing older and younger donor tissue, 2-5 whereas other studies suggest that there is a relationship between endothelial cell loss and donor age. 6 -8The Cornea Donor Study (CDS) has evaluated the effect of donor age on 5-year graft survival in eyes undergoing cornea transplantation for a corne...