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
University of Miami
100 participants
Jul 12, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- 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 Criteria5
- 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
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Interventions
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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06261346