NCT06261346NARecruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
University of Miami
Start Date
7/15/2024
Completion Date
12/31/2027
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.
Eligibility Criteria
Age Range: 18 years to 80 years
Inclusion Criteria:
* undergoing endothelial keratoplasty (DSEK or DMEK) at the Bascom Palmer Eye Institute or Price Vision Group, using corneal graft tissue within 14 days of preservation
Exclusion Criteria:
* History of corneal transplantation in the study eye, Best corrected visual acuity (BCVA) worse than 20/40 in the contralateral eye, systemic immunosuppression, previous intraocular surgical procedures (other than cataract surgery) such as glaucoma tubes or silicone oil.
The following special populations will be excluded.
* Adults unable to consent
* Pregnant women
* Prisoners
Interventions
PROCEDURE
Endothelial keratoplasty
BIOLOGICAL
PRGF
Conditions
Fuchs' Endothelial DystrophyCorneal Edema
Locations
Bascom Palmer Eye Institute
Miami, Florida 33136
United States
Price Vision Group
Indianapolis, Indiana 46260
United States