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

NCT ID: NCT01284101

Last Updated: 2011-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Cell Loss With Different Insertion Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Forceps delivery of donor graft

Using the forceps to insert the donor graft.

Group Type ACTIVE_COMPARATOR

Forceps for delivery of the donor graft

Intervention Type DEVICE

Use of the forceps for delivery of the donor graft into the eye.

Tan Endoglide for insertion of the donor graft

Use of the Tan Endoglide for insertion of the donor graft.

Group Type EXPERIMENTAL

Use of the Tan Endoglide to insert the donor graft

Intervention Type DEVICE

Using the Tan Endoglide to insert the donor graft into the eye

Interventions

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Use of the Tan Endoglide to insert the donor graft

Using the Tan Endoglide to insert the donor graft into the eye

Intervention Type DEVICE

Forceps for delivery of the donor graft

Use of the forceps for delivery of the donor graft into the eye.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Toronto Western Hospital, University of Toronto

Locations

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Toronto Western Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Allan R Slomovic, MA MD

Role: CONTACT

416-603-5832

Facility Contacts

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Allan Slomovic, MA MD

Role: primary

416-603-5389

Other Identifiers

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REB-10-0632-B

Identifier Type: -

Identifier Source: org_study_id

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