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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: Hexiris Microinvasive Scleral Trephine (MIST)

Detailed Description

It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system in adults aged 40 years or more. The primary goal of this new treatment is to reduce intraocular pressure in the affected eye.

The first five cases will be performed in the operating room. Safety data, including any serious adverse events occurring on Day 0 (surgery), will be reviewed by the safety monitor, who will issue a formal decision indicating whether the study may transition to the slit lamp or must continue in the operating room for the 20 subsequent patients.

The surgical technique is performed ab externo under topical anesthesia at the slit lamp.

Patients will be treated using the Hexiris MIST device along with a subconjunctival injection of mitomycin C (0.02-0.04%) using a sterile technique. There is postoperative care using topical antibiotics and steroids. The follow-up duration is 12-months post treatment with the Hexiris MIST device.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: edouard Al Chami, M.Sc.; Phone Number: 6474533253; Email: ealchami@triplehair.ca
• Study Contact Backup: Name: elodie chamberland, BSN RN; Phone Number: 5147045551; Email: elodie.chamberland@videotron.ca

Study Locations

• Canada
  • New Brunswick
    • Dieppe, New Brunswick, Canada, E1A 9T8
      • Recruiting
      • Eye Care Centre NB
      • Contact: Tatjana Lapierre; Phone Number: 6 506-830-1773; Email: lapierre5783@gmail.com
    • Miramichi, New Brunswick, Canada, E1N 1B2
      • Recruiting
      • Miramichi EyeNB & Surgical Centres of Excellence
      • Contact: Heather Hayne; Phone Number: 506-424-7086; Email: heatherhayne.sh@gmail.com
      • Contact: Courtney Mcevoy; Phone Number: 506-625-4904; Email: cournteymcevoy.sh@gmail.com
  • Ontario
    • Brampton, Ontario, Canada, L6Y 4M3
      • Recruiting
      • Prism Eye Institute Inc.
      • Contact: Mike Yang, MD; Phone Number: 605 905-456-3937; Email: mike.yang@prismeye.ca
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 0E8
      • Recruiting
      • Institut de L'Oeil des Laurentides
      • Contact: Janik Denis; Phone Number: 227 450-419-6345; Email: jdenis@institutdeloeil.com
      • Contact: Lisa Monteschio; Phone Number: 263 450-419-6345; Email: lmonteschio@institutdeloeil.com
    • Montreal, Quebec, Canada, H1V 1G5
      • Recruiting
      • Ophthalmology Clinic Bellevue
      • Contact: Nataliya Khrushch; Phone Number: 514-256-0007; Email: nkhrushch@cliniquebellevue.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: device intervention; treatment with Hexiris MIST	Device: Hexiris 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.; Other Names: subconjunctival mitomycin C injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure lowering	Mean reduction in IOP (Goldmann applanation tonometry)	change from baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Greater or equal to 20% reduction in intraocular pressure (IOP)	Proportion of patients achieving ≥20% IOP reduction	change from baseline to Months 6 and 12.
Surgical success	IOP 6-18 mmHg at Month 12 without additional surgery.	at Month 12
concomitant glaucoma medications	Change in the number of glaucoma medications	change from baseline at week 1 and Months 1, 2, 3, 6, 9 and 12.
Composite surgical success	IOP ≤ 21 mmHg and ≥20% reduction at Month 12 without additional glaucoma surgery, or clinically significant hypotony.	at Month 12
Bleb morphology	Bleb morphology and stability - 4 point grading: healthy; injected; diffused bleb; others.	at week 1 and Months 1, 2, 3, 6, 9 and 12.
Corneal thickness	Central corneal thickness (CCT) changes	change from baseline to Month 6.
Complications	Incidence of conjunctival erosion, hypotony-related complications (reported separately as numerical hypotony [IOP ≤ 5 mmHg] and clinical hypotony with complications).	at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Patients requiring Mitomycin C post treatment	Number of patients needing MMC injection after surgery.	at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Mitomycin C injection post treatment	Number of MMC injections needed post op per patient.	at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Safety - adverse events and device failures	reporting of adverse events and serious adverse events	day of surgery and at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.

Collaborators and Investigators

• Sponsor: Hexiris Inc

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: scleral trephine; surgical trabeculectomy; bleb-forming intervention
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 020-3028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No