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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

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Conditions

Fuchs' Endothelial DystrophyCorneal Edema

Locations

Bascom Palmer Eye Institute

Miami, Florida 33136

United States

Price Vision Group

Indianapolis, Indiana 46260

United States