Epidermal growth factor and insulin in use in corneal preservation: study design and objectives of a multi-center...

This study determines whether endothelial survival after penetrating keratoplasty is improved by adding the mitogens, human epidermal growth factor (hEGF), and human insulin to a chondroitin-sulfate-based corneal storage medium. It is a multicenter, prospective, double-masked, randomized trial that compares endothelial survival of human corneal transplants using donor corneas that have been stored in one of two media: DexSol (CSM with 1% dextran) or DexSol containing recombinant hEGF and human insulin. This article describes the study design and entry characteristics of the 105 recipient pairs. Each donor pair of corneas is transplanted on the same day into recipients who are matched by diagnosis and procedure. Clinical parameters assessed on day 1, week 1, and 3, 6 and 12 months postoperatively include graft clarity, epithelial integrity, corneal thickness, visual acuity, and intraocular pressure. Postoperative endothelial survival for both groups will be determined by morphometric analysis of endothelial cell images before storage and at 3, 6, and 12 months postoperatively. Such analysis will also identify differences in polymegathism (cell size) or pleomorphism (cell shape).