Recruiting

Endoglide vs. Endoserter

Sponsor:

University Health Network, Toronto

Code:

NCT01791075

Conditions

Fuch's Endothelial Dystrophy

Bullous Keratopathy, Unspecified Eye

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tan Endoglide

Endosaver

Study Details

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

Study ID

NCT01791075

Start date

Jan, 2012

Status verified date

Feb, 2013

Completion date

Jan, 2014

Anticipated

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Tan Endoglide

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

active comparator: Endosaver/serter

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

Interventions

Tan Endoglide

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

Endosaver

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

Primary outcome measure

  • Endothelial cell count after 6 months and 12 months [ Time Frame: 6,12 months post op ]

Central Contacts and Locations

Central contacts

Uri Elbaz, MD

4163175662urielbaz@gmail.com

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

University Health Network, Toronto

Last update posted

Feb 15, 2013

Last verified

Feb, 2013

Keywords

  • DSAEK
  • Tan Endoglide
  • Endosaver/Endoserter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2013-02-15.