NCT06261346

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and efficacy of brief intraoperative corneal endothelial graft incubation in plasma rich in growth factors (PRGF) for reducing postoperative endothelial cell loss.

Conditions

• Fuchs' Endothelial Dystrophy
• Corneal Edema

Interventions

Type	Name	Description
PROCEDURE	Endothelial keratoplasty	Surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea) with brief incubation of the donor tissue in PRGF prior to graft implantation. This incubation will be a one time procedure done to the tissue in the operating room. The endothelial keratoplasty is 30-45 minutes.
BIOLOGICAL	PRGF	Plasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient. PRGF incubation lasts 15 minutes. It is a one-time procedure performed on the tissue that will be done in the operating room prior to endothelial keratoplasty.

Timeline

• Start date: 2024-07-15
• Primary completion: 2027-10-30
• Completion: 2027-12-31
• First posted: 2024-02-15
• Last updated: 2026-04-09

Locations

2 sites across 1 country: United States