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

Recruiting in Palo Alto (17 mi)

Overseen byGeorges Durr, MD, FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

No Placebo Group

Trial Summary

What is the purpose of this trial?

The main goal of this study is to assess the severity of postoperative corneal astigmatism induced by implantation of the XEN Gel Stent compared to that induced by traditional filtering surgery (trabeculectomy and GDDs). Corneal astigmatism can be assessed using corneal topography, a non-invasive tool which provides an accurate estimate of corneal curvature in all meridians. To the best of our knowledge, no study has yet attempted to quantify the amount of astigmatism induced by the XEN Gel Stent.

Research Team

Georges Durr, MD, FRCSC

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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.

Inclusion Criteria

Ability to be followed for the entire duration of the study

I am 18 years old or older.

My eye pressure is too high or getting worse despite using all possible treatments.

See 1 more

Exclusion Criteria

Inability to provide informed consent

I am having surgery that includes removing a cataract.

I am under 18 years old.

See 3 more

Treatment Details

Interventions

Corneal topography: OPD-Scan (Diagnostic Test)
Corneal topography: Pentacam (Diagnostic Test)

Trial OverviewThe 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.

Participant Groups

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)