NCT06261346 Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
| NCT ID | NCT06261346 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Fuchs' Endothelial Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-07-15 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Alfonso L Sabater, MD
PRINCIPAL INVESTIGATOR
Bascom Palmer Eye Institute
Frequently Asked Questions
Who can join the NCT06261346 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Fuchs' Endothelial Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06261346 currently recruiting?
Yes, NCT06261346 is actively recruiting participants. Contact the research team at asabater@med.miami.edu for enrollment information.
Where is the NCT06261346 trial being conducted?
This trial is being conducted at Miami, United States, Indianapolis, United States.
Who is sponsoring the NCT06261346 clinical trial?
NCT06261346 is sponsored by University of Miami. The principal investigator is Alfonso L Sabater, MD at Bascom Palmer Eye Institute. The trial plans to enroll 100 participants.