Recruiting

Tan EndoGlide vs. Busin Glide

Sponsor:

University Health Network, Toronto

Code:

NCT01284543

Conditions

Endothelial Cell Loss With Different Insertion Devices

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of the Tan EndoGlide to insert donor graft

Busin Glide for delivery of the donor graft

Study Details

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 Busin glide.

Conditions

Endothelial Cell Loss With Different Insertion Devices

Study ID

NCT01284543

Start date

Jan, 2011

Status verified date

Jan, 2011

Primary completion date

Jan, 2012

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: Busin glide delivery of donor graft

Use of the Busin glide to insert the donor graft

experimental: Tan EndoGlide for insertion of the donor graft

Use of the Tan EndoGlide for insertion of the donor graft

Interventions

Use of the Tan EndoGlide to insert donor graft

Using the Tan EndoGlide to insert donor graft into the eye

Busin Glide for delivery of the donor graft

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

Primary outcome measure

  • Endothelial cell counts at 1, 3, 6 and 12 months postoperatively [ Time Frame: 1 year ]
  • Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

David S Rootman, MD

1-416-545-1900d.rootman@utoronto.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5B1L2

Contacts

David S Rootman, MD

1-416-545-1900d.rootman@utoronto.ca

Principal Investigator:

David S Rootman, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 27, 2011

Last verified

Jan, 2011

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 2011-01-27.