Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

Not Applicable

Recruiting

• Conditions: Corneal Edema; Fuchs' Endothelial Dystrophy
• Interventions: Procedure: Endothelial keratoplasty; Biological: PRGF

• Registration Number: NCT06261346
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-07-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Endothelial keratoplasty	Participants will undergo endothelial keratoplasty procedure. Participants will be followed up for up to 1 year.
PRGF group	PRGF	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.
PRGF group	Endothelial keratoplasty	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.

Primary Outcome Measures

Name	Time	Method
Change in endothelial cell percentage	Baseline, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Endothelial cell density	Baseline, up to 12 months	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
Number of re-bubbling for graft attachment	Up to 2 months	The number of air re-injections for graft attachment within the first 2 months will be assessed.
Visual acuity measured by snellen chart	Up to 12 months	Participants will have their best corrected visual acuity measured as values expressed using the Snellen chart.
Corneal endothelial cell density	Up to 12 months	Central corneal endothelial cell density by specular microscopy (cells/millimeter\^2)

Trial Locations

Locations (2)

Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States