Recruiting

MIST

Sponsor:

Hexiris Inc

Code:

NCT07358650

Conditions

Primary Open Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Hexiris Microinvasive Scleral Trephine (MIST)

Study Details

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

Study ID

NCT07358650

Start date

Jan 15, 2026

Status verified date

Jan, 2026

Completion date

Mar 15, 2027

Anticipated

Primary completion date

Feb 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: device intervention

treatment with Hexiris MIST

Interventions

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.

Primary outcome measure

  • Intraocular pressure lowering [ Time Frame: change from baseline to Month 6 ]

Central Contacts and Locations

Central contacts

edouard Al Chami, M.Sc.

6474533253ealchami@triplehair.ca

elodie chamberland, BSN RN

5147045551elodie.chamberland@videotron.ca

Locations

Eye Care Centre NB

Recruiting

Dieppe, New Brunswick, Canada, E1A 9T8

Contacts

Tatjana Lapierre

506-830-1773lapierre5783@gmail.com

Miramichi EyeNB & Surgical Centres of Excellence

Recruiting

Miramichi, New Brunswick, Canada, E1N 1B2

Contacts

Heather Hayne

506-424-7086heatherhayne.sh@gmail.com

Courtney Mcevoy

506-625-4904cournteymcevoy.sh@gmail.com

Prism Eye Institute Inc.

Recruiting

Brampton, Ontario, Canada, L6Y 4M3

Contacts

Mike Yang, MD

905-456-3937mike.yang@prismeye.ca

Institut de l'oeil des Laurentides

Recruiting

Boisbriand, Quebec, Canada, J7H 0E8

Contacts

Janik Denis

450-419-6345jdenis@institutdeloeil.com

Lisa Monteschio

450-419-6345lmonteschio@institutdeloeil.com

Ophthalmology Clinic Bellevue

Recruiting

Montreal, Quebec, Canada, H1V 1G5

Contacts

Nataliya Khrushch

514-256-0007nkhrushch@cliniquebellevue.com

More Information

Sponsor

Hexiris Inc

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

  • scleral trephine
  • surgical trabeculectomy
  • bleb-forming intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hexiris Inc on 2026-01-22.