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XEN Gel Stent vs Traditional Filtering Surgery for Glaucoma (Topo-XEN Trial)

N/A
Recruiting
Led By Georges Durr, MD, FRCSC
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 18 years or older
Eyes with an IOP above target and/or progressing on maximally tolerated medical therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 months, 6 months, 12 months
Awards & highlights

Topo-XEN Trial Summary

This trial will compare the amount of postoperative corneal astigmatism induced by the XEN Gel Stent to that induced by traditional filtering surgery.

Who is the study for?
This trial is for adults over 18 with glaucoma whose eye pressure isn't controlled by current medications. Participants must be able to give consent and commit to the full study duration. It's not suitable for those under 18, unable to consent, can't follow the study through, having cataract surgery at the same time, or with severe dry eye or other eye diseases besides glaucoma.Check my eligibility
What is being tested?
The study compares how much corneal astigmatism (irregular curvature of the eye's surface) is caused by XEN Gel Stent implantation versus traditional surgeries like trabeculectomy and tube shunts. Corneal topography tools Pentacam and OPD-Scan are used non-invasively to measure changes in corneal shape after these procedures.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, generally corneal topography is a safe procedure with minimal risks. Potential side effects from surgical interventions may include discomfort in the eye, temporary vision disturbances, infection risk, or increased intraocular pressure.

Topo-XEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My eye pressure is too high or getting worse despite using all possible treatments.

Topo-XEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Keratometric values (OPD-Scan)
Keratometric values (Pentacam)
Secondary outcome measures
Best-corrected visual acuity change
Ganglion cell layer thickness change
Intraocular pressure change
+2 more

Topo-XEN Trial Design

3Treatment groups
Experimental Treatment
Group I: XEN Gel Stent implantationExperimental Treatment2 Interventions
Participants suffering from glaucoma who are candidates for XEN Gel Stent implantation
Group II: TrabeculectomyExperimental Treatment2 Interventions
Participants suffering from glaucoma who are candidates for trabeculectomy
Group III: GDD implantationExperimental Treatment2 Interventions
Participants suffering from glaucoma who are candidates for GDD implantation (BGI or AGV)

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
365 Previous Clinical Trials
129,219 Total Patients Enrolled
7 Trials studying Glaucoma
380 Patients Enrolled for Glaucoma
AllerganIndustry Sponsor
781 Previous Clinical Trials
275,703 Total Patients Enrolled
91 Trials studying Glaucoma
49,026 Patients Enrolled for Glaucoma
Georges Durr, MD, FRCSCPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
2 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Corneal topography: OPD-Scan Clinical Trial Eligibility Overview. Trial Name: NCT04602923 — N/A
Corneal topography: OPD-Scan 2023 Treatment Timeline for Medical Study. Trial Name: NCT04602923 — N/A
Glaucoma Research Study Groups: XEN Gel Stent implantation, Trabeculectomy, GDD implantation
Glaucoma Clinical Trial 2023: Corneal topography: OPD-Scan Highlights & Side Effects. Trial Name: NCT04602923 — N/A

Frequently Asked Questions

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

What is the cap on total enrollees in this clinical research?

"Yes, the clinicaltrials.gov database reveals that this medical trial is presently recruiting individuals in need of a potential solution to their condition. The study was initially posted on November 4th 2020 and subsequently updated on May 30th 2022. A total of 90 patients must be enrolled across one location for the experiment to proceed."

Answered by AI

Are there vacated positions available in this clinical research project?

"Yes, the clinical trial is still open for enrollment according to information hosted on clinicialtrials.gov. The study was originally launched in November 4th 2020 and its data has been refreshed as recently as May 30th 2022."

Answered by AI

What is the key purpose of this clinical research?

"This medical trial, assessed across Baseline, 2 months, 6 months and 12 month time frames aims to measure Keratometric values using a Pentacam. Secondary outcomes include an evaluation of Ganglion cell layer (GCL+) thickness captured through Spectral Domain Optical Coherence Tomography (SD-OCT), Intraocular pressure control via Goldmann applanation tonometry and Visual field change evaluated by automated Humphrey 24-2 perimetry assessment."

Answered by AI
~17 spots leftby Jan 2025