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

NCT07358650 | Recruiting

• 1 other identifier: 020-3028
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

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.

Conditions

Primary Open Angle Glaucoma

Keywords

scleral trephine; surgical trabeculectomy; bleb-forming intervention

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure lowering

  Mean reduction in IOP (Goldmann applanation tonometry)

  change from baseline to Month 6

Secondary Outcomes (10)

• Greater or equal to 20% reduction in intraocular pressure (IOP)

  change from baseline to Months 6 and 12.

• Surgical success

  at Month 12

• concomitant glaucoma medications

  change from baseline at week 1 and Months 1, 2, 3, 6, 9 and 12.

• Composite surgical success

  at Month 12

• Bleb morphology

  at week 1 and Months 1, 2, 3, 6, 9 and 12.

Study Arms (1)

device intervention

EXPERIMENTAL

treatment with Hexiris MIST

Device: Hexiris Microinvasive Scleral Trephine (MIST)

Interventions

Hexiris Microinvasive Scleral Trephine (MIST) DEVICE

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.

Also known as: subconjunctival mitomycin C injection

device intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hexiris Inc: lead

Study Sites (5)

Eye Care Centre NB

Dieppe, New Brunswick, E1A 9T8, Canada

RECRUITING

Miramichi EyeNB & Surgical Centres of Excellence

Miramichi, New Brunswick, E1N 1B2, Canada

RECRUITING

Prism Eye Institute Inc.

Brampton, Ontario, L6Y 4M3, Canada

RECRUITING

Institut de l'oeil des Laurentides

Boisbriand, Quebec, J7H 0E8, Canada

RECRUITING

Ophthalmology Clinic Bellevue

Montreal, Quebec, H1V 1G5, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

edouard Al Chami, M.Sc.

CONTACT

6474533253; ealchami@triplehair.ca

elodie chamberland, BSN RN

CONTACT

5147045551; elodie.chamberland@videotron.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, open-label, non-randomized, single-arm, first-in-human clinical study: MIST + MMC: Subconjunctival MMC (0.02-0.04%) MMC will be injected subconjunctivally using a sterile technique, either prior to or following the procedure, at the surgeon's discretion.

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)