Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK

Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01284543

Enrollment

Registered

2011-01-27

Start date

2011-01-31

Completion date

Unknown

Last updated

2011-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Cell Loss With Different Insertion Devices

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.

Interventions

DEVICEUse of the Tan EndoGlide to insert donor graft

Using the Tan EndoGlide to insert donor graft into the eye

DEVICEBusin Glide for delivery of the donor graft

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Endothelial cell counts at 1, 3, 6 and 12 months postoperatively	1 year
Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively	1 year

Secondary

Measure	Time frame
Complications of surgery	1 year

Countries

Canada

Contacts

Primary ContactDavid S Rootman, MD

d.rootman@utoronto.ca1-416-545-1900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026