Epidermal growth factor and insulin use in corneal preservation. Results of a multi-center trial. The Corneal Preservation Study Group.

Abstract

The ability of DexSol medium, supplemented with two growth factors, human epidermal growth factor (hEGF) and human insulin, to improve long-term endothelial survival after penetrating keratoplasty was evaluated in a multi-center, randomized, prospective, double-masked clinical trial. Donor cornea pairs, one stored in DexSol and the other in DexSol with hEGF (10 ng/ml) and human insulin (10 micrograms/ml) (ProCell), were transplanted into 105 pairs of recipients matched by diagnosis and procedure and followed postoperatively for graft and endothelial survival. No primary donor failures occurred in either group. Graft clarity did not differ between the ProCell and DexSol groups at all postoperative periods: 3 months (98% versus 99%), 6 months (94% versus 98%), and 1 year (95% versus 97%), respectively. Postoperative complications (e.g., glaucoma, rejection) occurred with comparable frequencies in both groups. Mean endothelial cell loss did not significantly differ between the ProCell and DexSol groups at 3 months (5.7% versus 5.1%), 6 months (8.1% versus 10.1%), and 1 year (12.3% versus 15.6%), respectively. Similarly, there were no clinically and statistically significant differences in other endothelial morphometric parameters. The use of corneas stored in DexSol medium with added hEGF and insulin in corneal transplantation resulted in a safety and efficacy profile comparable with that observed in patients receiving DexSol-stored corneas; however, there were no clinically and statistically significant differences in postoperative endothelial morphometric parameters.