Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK

Not Applicable

• Conditions: Endothelial Cell Loss With Different Insertion Devices

• Registration Number: NCT01284543
• Lead Sponsor: University Health Network, Toronto

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 Busin glide.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-25
• Last Update Submitted: 2011-01-25
• Study First Posted: 2011-01-27
• Last Update Posted: 2011-01-27
• Primary Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endothelial cell counts at 1, 3, 6 and 12 months postoperatively	1 year
Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively	1 year

Secondary Outcome Measures

Name	Time	Method
Complications of surgery	1 year

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada