Study of Plasma Rich in Growth Factors During Corneal Endothelial Transplant to Reduce Cell Loss Safety and Effectiveness of Brief Graft Incubation in PRGF for Fuchs Endothelial Dystrophy and Corneal Edema

What this Trial Is About

Researchers are evaluating the safety and effectiveness of briefly incubating corneal endothelial grafts in plasma rich in growth factors PRGF during surgery to reduce cell loss after transplantation. This study focuses on patients with Fuchs Endothelial Dystrophy or Corneal Edema undergoing endothelial keratoplasty. It aims to understand if this incubation step can help protect the corneal cells postoperatively. Participants will be randomly assigned to one of two groups. One group will have their donor corneal tissue incubated with PRGF for 15 minutes during the operation before endothelial keratoplasty, a surgical procedure lasting 30-45 minutes that replaces the inner corneal cell layer. The other group will receive the standard endothelial keratoplasty without PRGF incubation. Both groups will be followed for up to one year to monitor outcomes. Throughout the study, participants will undergo assessments including measurements of endothelial cell percentage at baseline and 6 months, corneal endothelial cell density up to 12 months, changes in cell density, visual acuity tests using the Snellen chart, and the number of re-bubbling procedures needed for graft attachment within 2 months. These evaluations will help determine the impact of PRGF incubation on graft success and eye health over time.

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation