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NCT06261346 · ClinicalTrials.gov registry record · NA
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
A NA study of Fuchs Endothelial Dystrophy and Corneal Edema, sponsored by University of Miami.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT06261346: Recruiting NA study of Fuchs Endothelial Dystrophy and Corneal Edema, sponsored by University of Miami.
NCT06261346 is a NA study of Fuchs Endothelial Dystrophy and Corneal Edema that is actively recruiting participants, run by University of Miami. The registered enrollment target is 100 participants, below the 483-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06261346, a NA study of Fuchs Endothelial Dystrophy and Corneal Edema, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Endothelial keratoplasty
- BIOLOGICAL PRGF
Study Locations (2)
Florida
- Bascom Palmer Eye Institute - Miami
Indiana
- Price Vision Group - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-07-12 |
| Est. Completion | 2026-10-30 |
| Phase | NA |
What NCT06261346 shows while recruiting
NCT06261346 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Fuchs Endothelial Dystrophy appearing as the primary indexed condition, and to 2 interventions - of which Endothelial keratoplasty is the first listed.
NCT06261346 reports a single indexed study location in Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT06261346 about?
NCT06261346 is a clinical study titled "Plasma Rich in Growth Factors in Corneal Endothelial Transplantation". 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.
What is the current status of trial NCT06261346?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-07-12. Estimated completion is 2026-10-30.
What conditions does trial NCT06261346 study?
This clinical trial studies the following conditions: Fuchs Endothelial Dystrophy, Corneal Edema.
What interventions are being tested in trial NCT06261346?
The interventions under investigation include: Endothelial keratoplasty (PROCEDURE), PRGF (BIOLOGICAL).
Who is sponsoring clinical trial NCT06261346?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06261346 being conducted?
This trial has 2 study locations across Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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