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

University Health Network, Toronto

Status: Unknown

Conditions: Endothelial Cell Loss With Different Insertion Devices

Treatments: Device: Forceps for delivery of the donor graft; Device: Use of the Tan Endoglide to insert the donor graft

Study type: Interventional

Funder types: Other

Identifiers

NCT01284101

REB-10-0632-B

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Forceps delivery of donor graft

Active Comparator group

Description:

Using the forceps to insert the donor graft.

Treatment:

Device: Forceps for delivery of the donor graft

Tan Endoglide for insertion of the donor graft

Experimental group

Description:

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

Treatment:

Device: Use of the Tan Endoglide to insert the donor graft