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

Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

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.

Study Overview

• Status: Unknown
• Conditions: Endothelial Cell Loss With Different Insertion Devices
• Intervention / Treatment: Device: Busin Glide for delivery of the donor graft; Device: Use of the Tan EndoGlide to insert donor graft

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1L2
      • Recruiting
      • Toronto Western Hospital
      • Contact: David S Rootman, MD; Phone Number: 1-416-545-1900; Email: d.rootman@utoronto.ca
      • Principal Investigator: David S Rootman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Busin glide delivery of donor graft; Use of the Busin glide to insert the donor graft	Device: Busin Glide for delivery of the donor graft; Use of the forceps for delivery of the donor graft into the eye
Experimental: Tan EndoGlide for insertion of the donor graft; Use of the Tan EndoGlide for insertion of the donor graft	Device: Use of the Tan EndoGlide to insert donor graft; Using the Tan EndoGlide to insert donor graft into the eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Complications of surgery	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): January 27, 2011
• Last Update Submitted That Met QC Criteria: January 25, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: REB-10-0631-B