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.
RCT Entities:
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.
Authors: Steven J Petsche; Dimitri Chernyak; Jaime Martiz; Marc E Levenston; Peter M Pinsky Journal: Invest Ophthalmol Vis Sci Date: 2012-02-21 Impact factor: 4.799
Authors: Peter W Rieck; Ruth M von Stockhausen; Sylvia Metzner; Christian Hartmann; Yves Courtois Journal: Graefes Arch Clin Exp Ophthalmol Date: 2003-09-06 Impact factor: 3.117