RecruitingNot ApplicableNCT06261346

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

Sponsor

University of Miami

Enrollment

100 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Fuchs' Endothelial Dystrophy Corneal Edema

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Endothelial keratoplasty and a biological treatment called PRGF for people with corneal edema and fuchs' endothelial dystrophy. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndothelial keratoplasty

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.

BIOLOGICALPRGF

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.