RecruitingNot Applicable

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

United States100 participantsStarted 2024-07-15

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in endothelial cell percentage

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT06261346

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-30

Contact for this trial

Alfonso L Sabater, MD

3053266326 asabater@med.miami.edu

View on ClinicalTrials.gov More Fuchs' Endothelial Dystrophy trials