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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT01284543

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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)

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Complications of surgery [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5B1L2

Sponsors and Collaborators

University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01284543

Other Study ID Numbers:

REB-10-0631-B

First Posted:

Jan 27, 2011

Last Update Posted:

Jan 27, 2011

Last Verified:

Jan 1, 2011

Study Results

No Results Posted as of Jan 27, 2011