Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK

University Health Network, Toronto1 site in 1 country42 target enrollmentJanuary 2011

ConditionsEndothelial Cell Loss With Different Insertion Devices

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endothelial Cell Loss With Different Insertion Devices
Sponsor: University Health Network, Toronto
Enrollment: 42
Locations: 1
Primary Endpoint: Donor Graft Endothelial cell counts
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Forceps.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

January 2012

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Health Network, Toronto

Eligibility Criteria

Inclusion Criteria

•Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
•Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma.
•Ability to understand the nature of the procedure and give full informed consent.
•Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital.

Exclusion Criteria

•Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty.
•Patients with complex anterior segment pathology precluding successful DSAEK procedure.
•Patients not giving full informed consent to participate in the trial