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

Not Applicable

• Conditions: Endothelial Cell Loss With Different Insertion Devices
• Interventions: Device: Forceps for delivery of the donor graft; Device: Use of the Tan Endoglide to insert the donor graft

• Registration Number: NCT01284101
• 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 Forceps.

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: 2011-01-26
• Last Update Posted: 2011-01-26
• 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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Forceps delivery of donor graft	Forceps for delivery of the donor graft	Using the forceps to insert the donor graft.
Tan Endoglide for insertion of the donor graft	Use of the Tan Endoglide to insert the donor graft	Use of the Tan Endoglide for insertion of the donor graft.

Primary Outcome Measures

Name	Time	Method
Donor Graft Endothelial cell counts	1 year
Best corrected visual acuity	1 year

Secondary Outcome Measures

Name	Time	Method
Complications of surgery	1 year

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada