N/A
N=40
Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty
Fuchs Endothelial Dystrophy · Corneal Edema
Bottom Line
View on ClinicalTrials.gov: NCT00624221 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Endothelial Cell Loss — 28; 36 percentage of endothelial cell loss — p=0.10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Descemet's stripping endothelial keratoplasty (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Cornea Research Foundation of America
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endothelial Cell Loss |
28; 36 | 0.10 |
| SECONDARY Best Corrected Vision |
— | — |
| SECONDARY Graft Dislocation |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00624221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.