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

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 Overview

• Status: Recruiting
• Conditions: Corneal Edema; Fuchs' Endothelial Dystrophy
• Intervention / Treatment: Procedure: Endothelial keratoplasty; Biological: PRGF

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Price, PhD; Phone Number: 317-814-2990; Email: mprice@cornea.org
• Study Contact Backup: Name: Alfonso L Sabater, MD; Phone Number: 3053266326; Email: asabater@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Bascom Palmer Eye Institute
      • Contact: Alfonso L Sabater, MD; Phone Number: 305-326-6326; Email: asabater@med.miami.edu
      • Principal Investigator: Alfonso L Sabater, MD
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Price Vision Group
      • Contact: Marianne Price, PhD; Phone Number: 317-814-2990; Email: mprice@cornea.org
      • Principal Investigator: Marianne Price, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: Control group; Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal endothelial cell density	Central corneal endothelial cell density by specular microscopy (cells/millimeter^2)	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	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.	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.	Up to 2 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Beauty of Sight
• Investigators: Principal Investigator: Alfonso L Sabater, MD, Bascom Palmer Eye Institute

Publications and helpful links

General Publications

• Ishii N, Yamaguchi T, Yazu H, Satake Y, Yoshida A, Shimazaki J. Factors associated with graft survival and endothelial cell density after Descemet's stripping automated endothelial keratoplasty. Sci Rep. 2016 Apr 28;6:25276. doi: 10.1038/srep25276.
• Bhogal M, Balda MS, Matter K, Allan BD. Global cell-by-cell evaluation of endothelial viability after two methods of graft preparation in Descemet membrane endothelial keratoplasty. Br J Ophthalmol. 2016 Apr;100(4):572-8. doi: 10.1136/bjophthalmol-2015-307534. Epub 2016 Jan 6.
• Cho KS, Lee EH, Choi JS, Joo CK. Reactive oxygen species-induced apoptosis and necrosis in bovine corneal endothelial cells. Invest Ophthalmol Vis Sci. 1999 Apr;40(5):911-9.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Eye Diseases; Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases, Hereditary; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fuchs' Endothelial Dystrophy; Corneal Edema; Therapeutics; Surgical Procedures, Operative; Transplantation; Ophthalmologic Surgical Procedures; Cell- and Tissue-Based Therapy; Biological Therapy; Tissue Transplantation; Refractive Surgical Procedures; Corneal Transplantation; Descemet Stripping Endothelial Keratoplasty
• Other Study ID Numbers: 20230420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No