Study to Evaluate Safety and Performance of PRESERFLO MicroShunt XI Implant in Adults with Primary Open Angle Glaucoma

What this Trial Is About

Researchers are evaluating the safety and performance of the PRESERFLO17 MicroShunt XI device in patients with primary open angle glaucoma whose intraocular pressure IOP remains above 18 mmHg and up to 35 mmHg despite maximum tolerated medical therapy, or in cases where glaucoma progression requires surgery. This prospective, multicenter, single-arm post-market follow-up study focuses on this device, which is designed to help lower eye pressure by creating a channel for fluid to flow from the front chamber of the eye to a bleb under the conjunctiva. The PRESERFLO17 MicroShunt XI is implanted surgically by trained ophthalmologists or surgeons. The device works by shunting aqueous humor from the anterior chamber to a lower pressure bleb under the conjunctiva and Tenons capsule, helping to reduce IOP. This study does not include a control group or collect biospecimens. Participants receive the MicroShunt XI implant as part of their glaucoma treatment. Participants will be involved in assessments to monitor the safety and performance of the device, including measuring changes in intraocular pressure from screening through 12 months after implantation. The research team will track the proportion of eyes showing changes in IOP at 12 months. The study does not involve genetic or tissue sample collection. Total participation lasts up to one year, during which safety and performance data will be collected and evaluated.

PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group