A Multicenter, First-in-Human Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system. This medical device includes a sclerectomy punch and injector assembly. It is a multicenter, open-label, non-randomized, single-arm study. Adults aged 40 years or more will be enrolled if the POAG is inadequately controlled by topical drug therapies. Only one eye per subject will be treated. The study will be performed on the first five patients in the operating room and the subsequent 20 patients will be treated under a slit-lamp in an aseptic environment (external patient clinic).Once treated with the MIST device, patients will return the next day, 1 week later and 1, 2, 3, 6, 9 and 12 months later. During these follow-up visits, the ophthalmologist will examine the eye and take measurements of the intraocular pressure.
• Adults ≥ 40 years with uncontrolled mild to moderate POAG.
• IOP ≥ 18 mmHg on ≥1 topical IOP-lowering medications.
• Open angle on gonioscopy
• Clear cornea and healthy ocular surface
• Capable of giving informed consent, willingness to participate in the trial, and adhering to follow-up
• Glaucomatous visual field loss in one or both eyes at presentation on any of these criteria:
‣ Reproducible and reliable visual field defects on 2 consecutive fields
⁃ Mild, moderate or advanced disease on mean deviation according to Hodapp classification
⁃ Healthy, mobile conjunctiva in the target quadrant (superior bulbar region)
⁃ Best-corrected Snellen visual acuity of 20/100 or better
⁃ Visual field mean deviation no worse than -18.0 dB (without dense paracentral scotomas)
• No anticipated need for other ocular surgeries (e.g., cataract) within 3 months of post-enrollment