Recruiting

Plasma Rich in Growth Factors

Sponsor:

University of Miami

Code:

NCT06261346

Conditions

Fuchs' Endothelial Dystrophy

Corneal Edema

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Endothelial keratoplasty

PRGF

Study Details

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.

Conditions

Fuchs' Endothelial Dystrophy

Corneal Edema

Study ID

NCT06261346

Start date

Jul 15, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PRGF group

Participants tissue will be incubated in plasma rich in growth factors prior to endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.

active comparator: Control group

Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.

Interventions

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.

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.

Primary outcome measure

  • Change in endothelial cell percentage [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Alfonso L Sabater, MD

3053266326asabater@med.miami.edu

Marianne Price, PhD

317-814-2990mprice@cornea.org

Locations

Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Alfonso L Sabater, MD

305-326-6326asabater@med.miami.edu

Principal Investigator:

Alfonso L Sabater, MD

Price Vision Group

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Marianne Price, PhD

317-814-2990mprice@cornea.org

Principal Investigator:

Marianne Price, PhD

More Information

Sponsor

University of Miami

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-09.