Using plasma rich in growth factors during corneal transplants
Official title: Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss
Run by University of Miami · NCT06261346 · Data updated 2026-11-12
This study tests if using plasma rich in growth factors during corneal transplants can help patients keep more healthy cells after surgery compared to standard methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Status | Recruiting |
| Started | July 15, 2024 |
| Main results expected | October 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 9, 2026 |
| Trial ID | NCT06261346 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals scheduled for endothelial keratoplasty at the participating institutions with corneal graft tissue preserved within 14 days.
✕Probably not a fit
Patients with a history of corneal transplantation in the study eye or those with significant visual impairment in the other eye may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and effectiveness of using plasma rich in growth factors (PRGF) to incubate corneal endothelial grafts during surgery. The goal is to reduce the loss of endothelial cells after the transplantation procedure. Patients undergoing endothelial keratoplasty at specific institutions will receive this treatment to assess its impact on postoperative outcomes. The study will involve a comparison of results from patients treated with PRGF versus standard procedures.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced cell loss for patients undergoing corneal transplantation.
How similar studies have gone: While the use of PRGF in other surgical contexts has shown promise, this specific application in corneal transplantation is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Bascom Palmer Eye Institute
Miami, Florida, United States Recruiting -
Price Vision Group
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Alfonso L Sabater, MD — Bascom Palmer Eye Institute
- Study coordinator: Alfonso L Sabater, MD
- Email: asabater@med.miami.edu
- Phone: 3053266326
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.