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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01284543
First received: January 24, 2011
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Endothelial Cell Loss With Different Insertion Devices
Device: Use of the Tan EndoGlide to insert donor graft
Device: Busin Glide for delivery of the donor graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Endothelial cell counts at 1, 3, 6 and 12 months postoperatively [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications of surgery [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: January 2011
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284543

Contacts
Contact: David S Rootman, MD 1-416-545-1900 d.rootman@utoronto.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5B1L2
Contact: David S Rootman, MD    1-416-545-1900    d.rootman@utoronto.ca   
Principal Investigator: David S Rootman, MD         
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr David Rootman, Toronto Western Hospital, University of Toronto
ClinicalTrials.gov Identifier: NCT01284543     History of Changes
Other Study ID Numbers: REB-10-0631-B
Study First Received: January 24, 2011
Last Updated: January 25, 2011
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on July 24, 2014