Study of the Hexiris MIST Device to Lower Eye Pressure in Adults 40 and Older with Primary Open-Angle Glaucoma

What this Trial Is About

Researchers are evaluating a new treatment for Primary Open-Angle Glaucoma POAG using the Hexiris Microinvasive Scleral Trephine MIST system, a medical device designed to reduce intraocular pressure IOP in adults aged 40 years or older whose glaucoma is not controlled by topical medications. This multicenter, open-label, single-arm study focuses on safety and performance, treating only one eye per participant. The study includes an initial phase with five patients treated in an operating room and a subsequent phase with twenty patients treated in a clinic setting under a slit lamp. Participants will receive treatment with the Hexiris MIST device combined with a subconjunctival injection of mitomycin C. The first five treatments occur in the operating room, after which safety data will determine if the remaining patients are treated in the clinic. The procedure is performed under topical anesthesia using a sterile technique. Postoperative care involves topical antibiotics and steroids. Follow-up visits are scheduled at the day after treatment, then at 1 week, and 1, 2, 3, 6, 9, and 12 months. During follow-up, ophthalmologists will examine the treated eye and measure intraocular pressure along with other assessments such as bleb morphology, corneal thickness, and medication use. Researchers will monitor for safety events and device performance throughout the one-year study period. The primary outcome is the change in intraocular pressure from baseline to 6 months, with several secondary outcomes tracked up to 12 months post-treatment.

Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma