Miramichi

Researchers are evaluating the Hexiris Microinvasive Scleral Trephine (MIST) system for treating Primary Open-Angle Glaucoma (POAG) in adults aged 40 years and older whose condition is not well controlled by topical drug therapies. This multicenter, open-label, non-randomized, single-arm study aims to reduce intraocular pressure (IOP) in the affected eye by creating a channel in the sclera. The study includes an initial safety phase with the first five patients treated in an operating room, followed by treatment of 20 patients in an outpatient clinic using a slit lamp in an aseptic environment. The treatment involves using the Hexiris MIST device, which includes a sclerectomy punch and injector assembly designed to remove a core of tissue to help lower IOP. Along with the device, patients receive a subconjunctival injection of mitomycin C at a concentration of 0.02-0.04% using sterile technique. The procedure is performed ab externo under topical anesthesia at the slit lamp. Postoperative care includes topical antibiotics and steroids. Participants will have follow-up visits the day after treatment, then at 1 week, and at 1, 2, 3, 6, 9, and 12 months afterward. During these visits, ophthalmologists will examine the treated eye and measure intraocular pressure. The primary outcome measured is the change in intraocular pressure from baseline to 6 months after treatment. The total follow-up period lasts for 12 months to monitor safety and performance of the device.