RecruitingNot ApplicableNCT07358650

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

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

Sponsor

Hexiris Inc

Enrollment

25 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Primary Open Angle Glaucoma

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

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of a new small device called MIST, which is implanted in the eye to lower pressure and treat primary open-angle glaucoma — the most common form of glaucoma. **You may be eligible if...** - You are 40 years or older - You have mild to moderate primary open-angle glaucoma - Your eye pressure is still too high (at least 18 mmHg) despite using at least one prescription eye drop - Your vision loss meets certain criteria but is not too advanced (mean deviation no worse than -18 dB) - You have a healthy eye surface and clear cornea **You may NOT be eligible if...** - You have a different type of glaucoma (such as angle-closure, inflammatory, or trauma-related) - You have had previous glaucoma surgery in the treatment area - Your eye pressure is above 35 mmHg - You have an active eye infection or inflammation - You are pregnant or planning to become pregnant without using reliable contraception - You have an artificial lens in front of the iris (anterior chamber IOL) - Your cornea is too thick (over 600 μm) or you have significant corneal disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHexiris Microinvasive Scleral Trephine (MIST)

The 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.