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Recruiting NCT06261346

Plasma Rich in Growth Factors in Corneal Endothelial Transplantation

No phase Interventional Fuchs' Endothelial Dystrophy Corneal Edema

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endothelial keratoplasty, PRGF.
Who it may be relevant to
Registry conditions: Fuchs' Endothelial Dystrophy, Corneal Edema. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Efficacy of Brief Intraoperative Corneal Endothelial Graft Incubation in Plasma Rich in Growth Factors (PRGF) for Reducing Postoperative Endothelial Cell Loss

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.

Interventions

  • 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.

Primary outcome measures

  • Change in endothelial cell percentage [Time frame: Baseline, 6 months]
Secondary outcome measures (4)
  • Corneal endothelial cell density [Time frame: Up to 12 months]
  • Change in Endothelial cell density [Time frame: Baseline, up to 12 months]
  • Visual acuity measured by snellen chart [Time frame: Up to 12 months]
  • Number of re-bubbling for graft attachment [Time frame: Up to 2 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Bascom Palmer Eye Institute — Miami
  • Price Vision Group — Indianapolis

Identifiers

NCT: NCT06261346 · 20230420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗