Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06261346
Status
Recruiting
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Conditions

  • Corneal Edema
  • Fuchs' Endothelial Dystrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Endothelial keratoplasty — PROCEDURE
    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 — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jul 15, 2024
Status verified
Apr 2026
Primary completion
Oct 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Bascom Palmer Eye InstituteMiamiFlorida33136
Alfonso L Sabater, MD
[email protected]
305-326-6326
Alfonso L Sabater, MD (PRINCIPAL_INVESTIGATOR)
Price Vision GroupIndianapolisIndiana46260
Marianne Price, PhD
[email protected]
317-814-2990
Marianne Price, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Bascom Palmer Eye Institute· Miami, FLPrice Vision Group· Indianapolis, IN

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