 |
|
A Randomized, Double-Masked Clinical Trial of Optisol-GS vs Chen Medium for Human Corneal Storage
Joel Naor, MD, MSc;
Allan R. Slomovic, MA, MD, FRCS(C);
Mary Chipman, MA;
David S. Rootman, MD, FRCS(C)
Arch Ophthalmol. 2002;120:1280-1285.
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.
From the Department of Ophthalmology, Toronto Western Hospital, University
Health Network, University of Toronto, Toronto, Ontario.
|
