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
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
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
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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
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 May 19, 2013