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 range18 Years

SexALL

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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.

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