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NCT00624221 · ClinicalTrials.gov registry record · NA
Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
A NA study of Fuchs Endothelial Dystrophy and Corneal Edema, sponsored by Cornea Research Foundation of America.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00624221: Completed NA study of Fuchs Endothelial Dystrophy and Corneal Edema, sponsored by Cornea Research Foundation of America.
NCT00624221 is a NA study of Fuchs Endothelial Dystrophy and Corneal Edema that has completed, run by Cornea Research Foundation of America. The registered enrollment target is 40 participants, below the 491-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00624221, a NA study of Fuchs Endothelial Dystrophy and Corneal Edema, has completed, sponsored by Cornea Research Foundation of America.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.
Primary Outcome
Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.
Conditions Studied
Interventions
- PROCEDURE Descemet's stripping endothelial keratoplasty
Study Locations (1)
Indiana
- Cornea Research Foundation of America - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-11 |
| Phase | NA |
What the finished NCT00624221 record still lists
NCT00624221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 491-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Fuchs Endothelial Dystrophy appearing as the primary indexed condition, and to 1 intervention - of which Descemet's stripping endothelial keratoplasty is the first listed.
NCT00624221 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00624221 about?
NCT00624221 is a clinical study titled "Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty". Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surge...
What is the current status of trial NCT00624221?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2006-01. Estimated completion is 2007-11.
What conditions does trial NCT00624221 study?
This clinical trial studies the following conditions: Fuchs Endothelial Dystrophy, Corneal Edema.
What interventions are being tested in trial NCT00624221?
The interventions under investigation include: Descemet's stripping endothelial keratoplasty (PROCEDURE).
Who is sponsoring clinical trial NCT00624221?
This trial is sponsored by Cornea Research Foundation of America, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00624221 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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