Use of the Tan EndoGlide to insert donor graft for Corneal Endothelial Cell Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Corneal Endothelial Cell Loss
Use of the Tan EndoGlide to insert donor graft - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial found that the Tan EndoGlide device caused less damage to cells during insertion of a donor corneal graft, as indicated by reduced cell loss at follow-up 1 year later, compared to the Busin glide.

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively
Complications of surgery
Endothelial cell counts at 1, 3, 6 and 12 months postoperatively

Trial Safety

Trial Design

2 Treatment Groups

Busin glide delivery of donor graft
1 of 2
Tan EndoGlide for insertion of the donor graft
1 of 2

Active Control

Experimental Treatment

42 Total Participants · 2 Treatment Groups

Primary Treatment: Use of the Tan EndoGlide to insert donor graft · No Placebo Group · N/A

Tan EndoGlide for insertion of the donor graft
Device
Experimental Group · 1 Intervention: Use of the Tan EndoGlide to insert donor graft · Intervention Types: Device
Busin glide delivery of donor graft
Device
ActiveComparator Group · 1 Intervention: Busin Glide for delivery of the donor graft · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,370 Previous Clinical Trials
471,830 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation.
You are able 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.