Hurst

This research aims to evaluate the rate of malposition and related clinical problems of the Hydrus Microstent device within 24 months after surgery in patients with primary open angle glaucoma. Participants will have an operable, age-related cataract and a diagnosis of glaucoma treated with up to four eye pressure-lowering medications. The study is a prospective, non-randomized, single-arm clinical trial sponsored by Alcon following acquisition of Ivantis, Inc. Participants will undergo uncomplicated cataract surgery using standard anesthesia and phacoemulsification, followed by implantation of a commercially available monofocal intraocular lens (IOL) and placement of the Hydrus Microstent device through the trabecular meshwork into Schlemm's canal. The Hydrus Microstent is a crescent-shaped nitinol device designed as a permanent implant to help fluid drainage in the eye. The study involves a screening visit, surgery on Day 0, and eight follow-up visits scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24. Researchers will monitor the occurrence of clinically significant device malposition and any related clinical effects during this 24-month postoperative period. Assessments will include visual acuity, intraocular pressure, optic nerve appearance, and other protocol-defined evaluations to ensure safety and device performance.