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Device

Tan EndoGlide vs Forceps for Reducing Cell Loss in Corneal Transplant

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

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial found that the Tan EndoGlide device causes less damage to cells during corneal transplant surgery, leading to fewer cell losses.

Who is the study for?

This trial is for patients with corneal decompensation who need a DSAEK procedure, which could include those with Fuchs dystrophy or previous failed cornea surgeries. Participants must understand the procedure and follow-up protocol at Toronto Western Hospital. It's not for those without consent, complex eye issues preventing DSAEK, or advanced scarring needing full cornea transplant.Check my eligibility

What is being tested?

The study compares two methods of inserting donor grafts in DSAEK surgery: using forceps versus the Tan EndoGlide device. The goal is to see if the Tan EndoGlide causes less damage to endothelial cells one year after surgery compared to traditional forceps.See study design

What are the potential side effects?

While specific side effects are not listed for this trial, generally such procedures may cause irritation, swelling, infection risk at the surgical site, and potential vision changes due to endothelial cell loss.

Eligibility Criteria

Inclusion Criteria

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

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I understand the procedure and agree to participate.

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I need surgery for corneal damage and possibly cataract surgery for better vision.

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

Donor Graft Endothelial cell counts

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: Forceps delivery of donor graftActive Control1 Intervention

Using the forceps to insert the donor graft.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,448 Total Patients Enrolled

Media Library

Tan EndoGlide (Device) Clinical Trial Eligibility Overview. Trial Name: NCT01284101 — N/A

Endothelial Cell Loss Syndrome Research Study Groups: Forceps delivery of donor graft, Tan Endoglide for insertion of the donor graft

Endothelial Cell Loss Syndrome Clinical Trial 2023: Tan EndoGlide Highlights & Side Effects. Trial Name: NCT01284101 — N/A

Tan EndoGlide (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01284101 — N/A

Frequently Asked Questions

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

Is participation in this experimental research available to the public presently?

"The clinicaltrials.gov page indicates that this medical study is no longer actively seeking patients, having been listed since January 1st 2011 and last updated on the 25th of the same month. Nonetheless, two other trials are currently open for enrolment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK

2011. "Prospective Randomized Study Comparing Endothelial Cell Loss Using the Tan EndoGlide With Forceps for Insertion of the Donor Graft in DSAEK". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01284101.