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Device

Tan EndoGlide vs. Busin Glide for Corneal Transplant Success

N/A

Waitlist Available

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation

Ability to understand the nature of the procedure and give full informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

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.

Who is the study for?

This trial is for individuals who can consent and have corneal diseases like Fuchs dystrophy or bullous keratopathy, among others. They need DSAEK surgery to improve vision and must follow the Toronto Western Hospital's protocol. Those with complex eye issues or severe scarring needing different surgery are excluded.Check my eligibility

What is being tested?

The study compares two devices for inserting donor corneal grafts during DSAEK surgery: the Tan EndoGlide and the Busin Glide. It aims to see if one causes less damage to cells in the cornea, measured by cell loss after one year.See study design

What are the potential side effects?

While specific side effects aren't listed, procedures involving corneal grafts may include risks of rejection, infection, inflammation, visual disturbances, or increased intraocular pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery for a damaged cornea, possibly with cataract surgery.

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I understand the procedure and can give my consent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively

Endothelial cell counts at 1, 3, 6 and 12 months postoperatively

Secondary outcome measures

Complications of surgery

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tan EndoGlide for insertion of the donor graftExperimental Treatment1 Intervention

Use of the Tan EndoGlide for insertion of the donor graft

Group II: Busin glide delivery of donor graftActive Control1 Intervention

Use of the Busin glide to insert the donor graft

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,472 Previous Clinical Trials

484,951 Total Patients Enrolled

Media Library

Busin Glide (Device) Clinical Trial Eligibility Overview. Trial Name: NCT01284543 — N/A

Endothelial Cell Loss Syndrome Research Study Groups: Busin glide delivery of donor graft, Tan EndoGlide for insertion of the donor graft

Endothelial Cell Loss Syndrome Clinical Trial 2023: Busin Glide Highlights & Side Effects. Trial Name: NCT01284543 — N/A

Busin Glide (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01284543 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any spots remaining in this trial?

"Contrary to expectation, this clinical trial is not currently accepting volunteers. The original post date was January 1st 2011 and the last update was made on January 25th of that same year. Despite its inactivity, there are 2 other trials actively recruiting at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2011. "Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01284543.