CompletedNot Applicable

Keratometric Change After XEN, Trabeculectomy and Tube Shunts

Canada50 participantsStarted 2020-11-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eyes with an IOP above target and/or progressing on maximally tolerated medical therapy; * Patients aged 18 years or older; * Ability to provide informed consent; * Ability to be followed for the entire duration of the study. Exclusion Criteria: * Patients less than 18 years old; * Inability to provide informed consent; * Inability to be followed for the entire duration of the study; * Patients undergoing surgery combined with cataract extraction; * Presence of severe dry eye disease; * Presence of ocular comorbidities other than glaucoma, such as corneal or retinal disease.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Keratometric values (OPD-Scan)

Timeframe: Baseline, 2 months, 6 months, 12 months

Keratometric values (Pentacam)

Timeframe: Baseline, 2 months, 6 months, 12 months

Trial details

NCT IDNCT04602923

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

View on ClinicalTrials.gov More Glaucoma, Open-Angle trials