Actively Recruiting
Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
Led by Hexiris Inc · Updated on 2026-01-22
25
Participants Needed
5
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 40 years or older with uncontrolled mild to moderate primary open-angle glaucoma.
- Intraocular pressure (IOP) of 18 mmHg or higher while using at least one topical IOP-lowering medication.
- Open angle confirmed by gonioscopy.
- Clear cornea and healthy ocular surface.
- Able to give informed consent, willing to participate, and follow-up.
- Glaucomatous visual field loss meeting criteria such as reproducible defects on two consecutive tests or mild to advanced disease by Hodapp classification.
- Healthy, mobile conjunctiva in the target treatment area.
- Best-corrected visual acuity of 20/100 or better.
- Visual field mean deviation no worse than -18.0 dB without dense paracentral scotomas.
- No planned ocular surgery (e.g., cataract) within 3 months after enrollment.
You will not qualify if you...
- Prior glaucoma filtering surgery in the treatment area.
- Angle-closure, neovascular, uveitic, or traumatic glaucoma.
- Conjunctival scarring, prior conjunctival surgery, or other pathology in the treatment area.
- Scleral thinning, staphyloma, or structural abnormalities in the treatment area.
- Uncontrolled intraocular pressure above 35 mmHg at screening.
- Active ocular infection or inflammation such as blepharitis, conjunctivitis, keratitis, or uveitis.
- Active or recent (within 6 months) iris neovascularization in the treatment area.
- Impaired episcleral venous drainage.
- Presence of anterior chamber intraocular lens.
- Uncontrolled bleeding disorders or anticoagulation therapy without proper perioperative management.
- Advanced glaucomatous optic neuropathy.
- Fuchs endothelial dystrophy with signs of endothelial decompensation.
- Central corneal thickness greater than 600 micrometers.
- Pathological myopia.
- Unable to comply with postoperative follow-up or treatment instructions.
- Women who are pregnant, nursing, planning pregnancy, or of childbearing potential not using reliable contraception as specified.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Eye Care Centre NB
Dieppe, New Brunswick, Canada, E1A 9T8
Actively Recruiting
2
Miramichi EyeNB & Surgical Centres of Excellence
Miramichi, New Brunswick, Canada, E1N 1B2
Actively Recruiting
3
Prism Eye Institute Inc.
Brampton, Ontario, Canada, L6Y 4M3
Actively Recruiting
4
Institut de l'oeil des Laurentides
Boisbriand, Quebec, Canada, J7H 0E8
Actively Recruiting
5
Ophthalmology Clinic Bellevue
Montreal, Quebec, Canada, H1V 1G5
Actively Recruiting
Research Team
E
edouard Al Chami, M.Sc.
CONTACT
E
elodie chamberland, BSN RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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