Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

University of Miami100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Fuchs' Endothelial Dystrophy Corneal Edema

Interventions

Endothelial keratoplastyPROCEDURE

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.

PRGFBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Bascom Palmer Eye Institute

Miami, Florida, United States

RECRUITING

Price Vision Group

Indianapolis, Indiana, United States

RECRUITING

Outcomes

Primary Outcomes

Change in endothelial cell percentage

Central corneal endothelial cell percentage will be assessed by specular microscopy and compared with the baseline donor endothelial cell percentage measured by the provider eye bank to determine endothelial cell changes.

Time frame: Baseline, 6 months

Secondary Outcomes

Corneal endothelial cell density

Central corneal endothelial cell density by specular microscopy (cells/millimeter\^2)

Time frame: Up to 12 months

Change in Endothelial cell density

Change in central corneal endothelial cell density will be assessed by specular microscopy (cells/millimeter\^2) and compared with the baseline donor endothelial cell density reported by the provider eye bank to determine endothelial cell loss

Time frame: Baseline, up to 12 months

Visual acuity measured by snellen chart

Participants will have their best corrected visual acuity measured as values expressed using the Snellen chart.

Time frame: Up to 12 months

Number of re-bubbling for graft attachment

The number of air re-injections for graft attachment within the first 2 months will be assessed.

Time frame: Up to 2 months

Central Contacts

Alfonso L Sabater, MD

CONTACT

3053266326 asabater@med.miami.edu

Marianne Price, PhD

CONTACT

317-814-2990 mprice@cornea.org

Data from ClinicalTrials.gov

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