A Prospective, Randomized, Single Center Study Evaluating Use of Surgeon- and Eye Bank-prepared Donor Tissue for Descemet's Stripping and Endothelial Keratoplasty, a Type of Cornea Transplant
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fuchs Endothelial Dystrophy
- Sponsor
- Cornea Research Foundation of America
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Endothelial Cell Loss
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •candidate for Descemet's stripping with endothelial keratoplasty
- •at least 21 years old
- •willing and able to return for scheduled follow-up visits
- •reads and signs Informed Consent document
Exclusion Criteria
- •visual acuity of less than 20/400 in fellow eye
- •known sensitivity to planned study concomitant medications
Outcomes
Primary Outcomes
Endothelial Cell Loss
Time Frame: 6 months after grafting
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.
Secondary Outcomes
- Best Corrected Vision(6 months and 1 year after grafting)
- Graft Dislocation(1 day to 1 month after grafting)