N/A Completed N=40 Randomized Double-blind Treatment

Study of Eye Bank Pre-cut Donor Grafts for Endothelial Keratoplasty

Fuchs Endothelial Dystrophy · Corneal Edema

Source: ClinicalTrials.gov NCT00624221 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2010

Primary outcomePrimary: Endothelial Cell Loss — 28; 36 percentage of endothelial cell loss — p=0.10

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Endothelial Cell Loss	28; 36	0.10
SECONDARY Best Corrected Vision	—	—
SECONDARY Graft Dislocation	—	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.