A randomized, double-masked clinical trial of Optisol-GS vs Chen Medium for human corneal storage.

OBJECTIVE To determine whether the clinical outcome of corneal transplantation performed with tissue stored in Chen Medium (CM; Chen Laboratories, Phoenix, Md) is superior to that of Optisol-GS (Chiron Ophthalmics, Irvine, Calif). DESIGN Randomized, double-masked trial. PARTICIPANTS AND SETTING Ninety patients undergoing corneal transplantation at a tertiary center. INTERVENTION Donor cornea pairs were stored, one in CM and the other in Optisol-GS, transplanted, and followed up for 3 months. MAIN OUTCOME MEASURES Endothelial cell loss (ECL) at 3 months. Secondary outcomes were thickness and epithelialization at days 1, 7, 30, and 90, as well as primary and secondary graft failure. RESULTS Mean percentages of ECL 3 months after surgery were similar for corneas stored in Optisol-GS and corneas stored in CM. The 95% confidence interval (CI) for the difference was -3.4% to 13.2%. Covariate-adjusted 95% CI was -6.1% to 9.1%. Pachymetry values were similar in the 2 treatment groups. Eighty-eight percent of the corneas stored in each medium achieved epithelialization of 75% to 100% of the surface area within 1 week after transplantation. No primary donor failures occurred in either group. One graft that was preserved in CM failed during the study period. CONCLUSION The clinical outcomes of corneal transplantation with tissue that was preserved in CM were similar to those of grafts preserved in Optisol-GS.