Actively Recruiting
Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors for Reducing Postoperative Endothelial Cell Loss
Led by University of Miami · Updated on 2026-04-09
100
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
B
Beauty of Sight
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of briefly incubating corneal endothelial grafts in plasma rich in growth factors (PRGF) during surgery to reduce cell loss after transplantation. This study focuses on patients with Fuchs' Endothelial Dystrophy or Corneal Edema undergoing endothelial keratoplasty. It aims to understand if this incubation step can help protect the corneal cells postoperatively. Participants will be randomly assigned to one of two groups. One group will have their donor corneal tissue incubated with PRGF for 15 minutes during the operation before endothelial keratoplasty, a surgical procedure lasting 30-45 minutes that replaces the inner corneal cell layer. The other group will receive the standard endothelial keratoplasty without PRGF incubation. Both groups will be followed for up to one year to monitor outcomes. Throughout the study, participants will undergo assessments including measurements of endothelial cell percentage at baseline and 6 months, corneal endothelial cell density up to 12 months, changes in cell density, visual acuity tests using the Snellen chart, and the number of re-bubbling procedures needed for graft attachment within 2 months. These evaluations will help determine the impact of PRGF incubation on graft success and eye health over time.
CONDITIONS
Brief Title
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing endothelial keratoplasty (DSEK or DMEK) using corneal graft tissue preserved within 14 days
- Aged between 18 and 80 years
- Able to provide informed consent
You will not qualify if you...
- History of corneal transplantation in the study eye
- Best corrected visual acuity worse than 20/40 in the opposite eye
- Using systemic immunosuppression
- Previous intraocular surgeries other than cataract surgery, such as glaucoma tubes or silicone oil
- Adults unable to consent
- Pregnant women
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 to 45 minutes (surgery)
Participants undergo endothelial keratoplasty surgery, with the donor tissue incubated in plasma rich in growth factors (PRGF) for 15 minutes prior to graft implantation for those in the experimental group.
1 surgery visit (in-person)
Duration - Up to 12 months
Participants are followed up to monitor corneal endothelial cell health and visual acuity, as well as to assess graft attachment and safety outcomes.
Approximately 6 follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Actively Recruiting
2
Price Vision Group
Indianapolis, Indiana, United States, 46260
Actively Recruiting
Research Team
A
Alfonso L Sabater, MD
M
Marianne Price, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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