NCT07358650 Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
| NCT ID | NCT07358650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hexiris Inc |
| Condition | Primary Open Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2027-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2026-01-15 with a primary completion date of 2027-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Uncontrolled IOP \> 35 mmHg at screening. * Active ocular infection or inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis). * Active or recent (within 6 months) iris neovascularization in the treatment quadrant * Impaired episcleral venous drainage * Anterior chamber intraocular lens * Patients with uncontrolled bleeding disorders or those receiving anticoagulation therapy without appropriate perioperative management * Advanced glaucomatous optic neuropathy. * Fuchs endothelial dystrophy with clinical signs of endothelial decompensation. * Central corneal thickness (CCT) \> 600 μm. * Pathological myopia. * Patients unable to comply with postoperative follow-up or treatment instructions * Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception as outlined below are excluded: * Hormonal methods and the intrauterine device (IUD) must be in use at least 30 days prior to first study drug administration * Barrier methods must be in use at least 14 days prior to study drug administration * Your male partner vasectomy must be completed 3 months prior to first study drug administration or a sperm count of 0 should be confirmed.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07358650 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Primary Open Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07358650 currently recruiting?
Yes, NCT07358650 is actively recruiting participants. Contact the research team at ealchami@triplehair.ca for enrollment information.
Where is the NCT07358650 trial being conducted?
This trial is being conducted at Dieppe, Canada, Miramichi, Canada, Brampton, Canada, Boisbriand, Canada and 1 additional location.
Who is sponsoring the NCT07358650 clinical trial?
NCT07358650 is sponsored by Hexiris Inc. The trial plans to enroll 25 participants.