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
Prior glaucoma filtering surgery (trabeculectomy, shunt or valve) in the treatment quadrant
Angle-closure, neovascular, uveitic, or traumatic glaucoma.
Eyes with conjunctival scarring, prior conjunctival surgery or other pathologies in the treatment quadrant
Eyes with scleral thinning, staphyloma, or structural abnormalities in the treatment quadrant
Single group
Hexiris Microinvasive Scleral Trephine (MIST)
DeviceThe punch needle of the Hexiris MIST device was designed to be injected securely into the conjunctiva/sclera and remove a core of tissue, creating a channel in the sclera of the eye for reduction of IOP.
Intraocular pressure lowering
Mean reduction in IOP (Goldmann applanation tonometry)
Greater or equal to 20% reduction in intraocular pressure (IOP)
Proportion of patients achieving ≥20% IOP reduction
Surgical success
IOP 6-18 mmHg at Month 12 without additional surgery.
concomitant glaucoma medications
Change in the number of glaucoma medications
Composite surgical success
IOP ≤ 21 mmHg and ≥20% reduction at Month 12 without additional glaucoma surgery, or clinically significant hypotony.
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