A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma

What this Trial Is About

Glaucoma is the second most common cause of blindness worldwide, after cataracts. This research evaluates the safety and effectiveness of the XEN63 gel stent implanted using two surgical methods: ab interno (inside the eye) and ab externo (outside the eye). The study focuses on measuring eye pressure and monitoring any adverse events in adults with glaucoma that is uncontrolled by medication or previous surgeries. Participants will receive the XEN63 gel stent implanted on Day 1, either through the ab interno or ab externo approach, depending on their assigned group. Each participant will be followed for 12 months to observe how well the device controls their intraocular pressure and to track any side effects. This study is conducted at multiple sites across the United States. During the study, participants will attend regular visits at a hospital or clinic where medical assessments and eye examinations will be performed to monitor the gel stent’s effect on glaucoma. Researchers will measure the percentage of participants achieving at least a 20% reduction in eye pressure while using the same or fewer medications, as well as record any adverse events over the 12-month period.

A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma