Hexiris MIST device to lower eye pressure in people 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

This trial will test the Hexiris MIST device to see if it lowers eye pressure in adults 40 and older whose primary open-angle glaucoma isn’t controlled by eye drops.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Hexiris Inc (Industry-sponsored)
• Locations: 5 sites (Dieppe, New Brunswick and 4 other locations)
• Trial ID: NCT07358650 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open-label, non-randomized single-arm study using the Hexiris Microinvasive Scleral Trephine (MIST) system to create a controlled scleral opening and reduce intraocular pressure. Adults 40 years and older with POAG inadequately controlled on topical medications will have one eye treated; the first five cases are performed in the operating room and the next 20 at a slit-lamp in an aseptic clinic setting. Treatment includes the MIST device plus a subconjunctival mitomycin C injection, with standard postoperative topical antibiotics and steroids. Participants return for scheduled IOP and safety checks the next day, at 1 week, and at 1, 2, 3, 6, 9 and 12 months after treatment.

Who should consider this trial

Good fit: Adults aged 40 or older with mild to moderate primary open-angle glaucoma, open angles, IOP ≥18 mmHg on at least one topical medication, healthy superior conjunctiva, and good overall ocular surface who can attend follow-up visits are ideal candidates.

Not a fit: Patients with prior glaucoma filtering surgery, narrow or closed angles, unhealthy conjunctiva in the target area, very advanced visual field loss beyond the study limits, or those needing additional ocular surgery within three months are unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, the device could provide a less invasive way to lower intraocular pressure and reduce reliance on medications or more invasive surgery.

How similar studies have performed: The technique is related to traditional trabeculectomy and other bleb-forming procedures that have a long track record of lowering IOP, but the Hexiris MIST device itself is novel with limited prior clinical data.

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.

Where this trial is running

Dieppe, New Brunswick and 4 other locations

• Eye Care Centre NB — Dieppe, New Brunswick, Canada (Recruiting)
• Miramichi EyeNB & Surgical Centres of Excellence — Miramichi, New Brunswick, Canada (Recruiting)
• Prism Eye Institute Inc. — Brampton, Ontario, Canada (Recruiting)
• Institut de l'oeil des Laurentides — Boisbriand, Quebec, Canada (Recruiting)
• Ophthalmology Clinic Bellevue — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: edouard Al Chami, M.Sc.

Conditions Primary Open Angle Glaucoma; scleral trephine; surgical trabeculectomy; bleb-forming intervention