EPIDERMAL GROWTH-FACTOR AND INSULIN USE IN CORNEAL PRESERVATION - RESULTS OF A MULTICENTER TRIAL

Purpose: The ability of DexSol medium, supplemented with two growth fa ctors, human epidermal growth factor (hEGF) and human insulin, to impr ove long-term endothelial survival after penetrating keratoplasty was evaluated in a multi-center, randomized, prospective, double-masked cl inical trial. Methods: Donor cornea pairs, one stored in DexSol and th e other in DexSol with hEGF (10 ng/ml) and human insulin (10 mu g/ml) (ProCell), were transplanted into 105 pairs of recipients matched by d iagnosis and procedure and followed postoperatively for graft and endo thelial survival. Results: No primary donor failures occurred in eithe r group. Graft clarity did not differ between the ProCell and DexSol g roups at all postoperative periods: 3 months (98% versus 99%), 6 month s (94% versus 98%), and 1 year (95% versus 97%), respectively. Postope rative complications (e.g., glaucoma, rejection) occurred with compara ble frequencies in both groups. Mean endothelial cell loss did not sig nificantly 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% vers us 15.6%), respectively. Similarly, there were no clinically and stati stically significant differences in other endothelial morphometric par ameters. Conclusions: 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 receiv ing DexSol-stored corneas; however, there were no clinically and stati stically significant differences in postoperative endothelial morphome tric parameters.