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

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01284101
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2

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 Forceps.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Cell Loss With Different Insertion Devices	Device: Use of the Tan Endoglide to insert the donor graft; Device: Forceps 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: Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK
• Study Start Date: Jan 1, 2011
• Anticipated Primary Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Forceps delivery of donor graft Using the forceps to insert the donor graft.	Device: Forceps 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 the donor graft; Using the Tan Endoglide to insert the donor graft into the eye

Outcome Measures

Primary Outcome Measures

1. Donor Graft Endothelial cell counts [1 year]

2. Best corrected visual acuity [1 year]

Secondary Outcome Measures

1. Complications of surgery [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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	M5T 2S8

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01284101
• Other Study ID Numbers: REB-10-0632-B
• First Posted: Jan 26, 2011
• Last Update Posted: Jan 26, 2011
• Last Verified: Jan 1, 2011

Study Results

No Results Posted as of Jan 26, 2011