MedTrace Logo

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

NCT06261346 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Fuchs' Endothelial Dystrophy
  • Corneal Edema

Interventions

PROCEDURE

Endothelial 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.

BIOLOGICAL

PRGF

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.

Sponsors & Collaborators

  • Beauty of Sight

    collaborator UNKNOWN

  • University of Miami

    lead OTHER

Principal Investigators

  • Alfonso L Sabater, MD · Bascom Palmer Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2027-10-30
Completion
2027-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06261346 on ClinicalTrials.gov