Comparing Vision Outcomes After XEN Glaucoma Gel Microstent Versus Traditional Trabeculectomy Surgery for Open Angle Glaucoma

What this Trial Is About

Researchers are evaluating two types of filtering glaucoma surgeriesXEN implant standalone procedure and classic trabeculectomy standalone procedurein patients with open angle glaucoma. This prospective, randomized, multicenter trial aims to compare postoperative best corrected visual acuity and refraction between these two standard surgical treatments. The study includes subjects eligible for both procedures and excludes those needing combined cataract surgery. Up to 196 eyes will be enrolled across four centers in Europe. Participants will be randomly assigned to receive either the XEN Glaucoma Gel Microstent implant, a minimally invasive surgery that preserves conjunctiva, or the classic trabeculectomy, a more invasive ab externo procedure considered the gold standard. Both groups follow the same inclusion and exclusion criteria, with no inclusion of both eyes from the same patient. Postoperative ophthalmic evaluations will be conducted at specified times to monitor recovery and outcomes. During the study, participants will have preoperative screening and visits scheduled at operation day, 1 day, 1 week, 2 weeks, then 1, 3, 6, and 12 months post-surgery. Assessments include measuring best corrected distance and near visual acuity, refraction changes, and safety and efficacy of both surgeries. The primary outcome is the proportion of patients with a best corrected distance visual acuity better than 0.3 logMAR at 1 week. Secondary outcomes include visual acuity changes and recovery time at other postoperative visits.

XEN Glaucoma Gel Stent Versus Trabeculectomy