Comparing Endoglide to Endoserter for DSAEK Graft Insertion

NCT01791075 | Unknown

• 1 other identifier: REB 10-0631-B
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the Tan EndoGlide with the new Endoserter injector in terms of damage to the donor corneal endothelium by comparing the endothelial cell loss at 1 month, 3 months, 6 months, and 1 year post DSAEK (Descemet's Stripping Automated Endothelial Keratoplasty)surgery. There is no data comparing this two injectors.

Conditions

Fuch's Endothelial Dystrophy; Bullous Keratopathy, Unspecified Eye

Keywords

DSAEK; Tan Endoglide; Endosaver/Endoserter

Outcome Measures

Primary Outcomes (1)

• Endothelial cell count after 6 months and 12 months

  The patients will be evaluated for endothelial cell loss 6 and 12 post surgery

  6,12 months post op

Secondary Outcomes (1)

• Visual acuity

  1 month and 3,6,12 months post surgery

Study Arms (2)

Tan Endoglide

ACTIVE COMPARATOR

Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide.

Device: Tan Endoglide

Endosaver/serter

ACTIVE COMPARATOR

Patients assigned to this arm will have their endothelial donor graft injected into the anterior chamber using the Endosaver/serter injector.

Device: Endosaver

Interventions

Tan Endoglide DEVICE

Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide

Tan Endoglide

Endosaver DEVICE

Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide

Also known as: Endoserter

Endosaver/serter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David S. Rootman, MD

  TWH - UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uri Elbaz, MD

CONTACT

4163175662; urielbaz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2013
• First Posted: February 13, 2013
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

CA (1)