The Effect of Donor Age on Corneal Transplantation Outcome: Results of the Cornea Donor Study
Received 7 December 2007; received in revised form 21 December 2007; accepted 2 January 2008.
Objective
To determine whether graft survival over a 5-year follow-up period using corneal tissue from donors older than 65 is similar to graft survival using corneas from younger donors.
One thousand ninety subjects undergoing corneal transplantation for a moderate-risk condition (principally Fuchs’ dystrophy or pseudophakic corneal edema); 11 subjects with ineligible diagnoses were not included.
Methods
Forty-three participating eye banks provided corneas from donors in the age range of 12 to 75 with endothelial cell densities of 2300 to 3300 cells/mm2, using a random approach without respect to recipient factors. The 105 participating surgeons at 80 sites were masked to information about the donor cornea including donor age. Surgery and postoperative care were performed according to the surgeons’ usual routines. Subjects were observed for 5 years.
Main Outcome Measures
Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque as to compromise vision for a minimum of 3 consecutive months.
Results
The 5-year cumulative probability of graft survival was 86% in both the <66.0 donor age group and the ≥66.0 donor age group (difference = 0%, upper limit of 1-sided 95% confidence interval = 4%). In a statistical model with donor age as a continuous variable, there was no significant relationship between donor age and outcome (P = 0.11). Three graft failures were due to primary donor failure, 8 to uncorrectable refractive error, 48 to graft rejection, 46 to endothelial decompensation (23 of which had a prior, resolved episode of probable or definite graft rejection), and 30 to other causes. Distributions of the causes of graft failure did not differ between donor age groups.
Conclusions
Five-year graft survivals for cornea transplants at moderate risk for failure are similar using corneas from donors ≥ 66.0 years and donors < 66.0. Surgeons and patients now have evidence that corneas comparable in quality to those used in this study from donors through age 75 are suitable for transplantation.
Correspondence to Robin L. Gal, MSPH, Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL 33647.
Manuscript no. 2007–1568.
Supported by the National Eye Institute, Bethesda, Maryland (cooperative agreement nos. EY12728, EY12358). Additional support provided by Eye Bank Association of America, Washington, DC; Bausch & Lomb, Inc., Rochester, New York; Tissue Banks International, Baltimore, Maryland; Vision Share, Inc., Apex, North Carolina; San Diego Eye Bank, San Diego, California; Cornea Society, Fairfax, Virginia; Katena Products, Inc., Denville, New Jersey; ViroMed Laboratories, Inc., Minnetonka, Minnesota; Midwest Eye-Banks (Michigan Eye-Bank, Illinois Eye-Bank), Ann Arbor, Michigan; Konan Medical Corp., Torrance, California; Eye Bank for Sight Restoration, New York, New York; SightLife, Seattle, Washington; Sight Society of Northeastern New York (Lions Eye Bank of Albany), Albany, New York; and Lions Eye Bank of Oregon, Portland, Oregon.
ABSTRACT