Actively Recruiting
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
Led by Hexiris Inc · Updated on 2026-01-22
25
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment for Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system, a medical device designed to reduce intraocular pressure (IOP) in adults aged 40 years or older whose glaucoma is not controlled by topical medications. This multicenter, open-label, single-arm study focuses on safety and performance, treating only one eye per participant. The study includes an initial phase with five patients treated in an operating room and a subsequent phase with twenty patients treated in a clinic setting under a slit lamp. Participants will receive treatment with the Hexiris MIST device combined with a subconjunctival injection of mitomycin C. The first five treatments occur in the operating room, after which safety data will determine if the remaining patients are treated in the clinic. The procedure is performed under topical anesthesia using a sterile technique. Postoperative care involves topical antibiotics and steroids. Follow-up visits are scheduled at the day after treatment, then at 1 week, and 1, 2, 3, 6, 9, and 12 months. During follow-up, ophthalmologists will examine the treated eye and measure intraocular pressure along with other assessments such as bleb morphology, corneal thickness, and medication use. Researchers will monitor for safety events and device performance throughout the one-year study period. The primary outcome is the change in intraocular pressure from baseline to 6 months, with several secondary outcomes tracked up to 12 months post-treatment.
CONDITIONS
Brief 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 aged 40 years or older with uncontrolled mild to moderate primary open-angle glaucoma
- Intraocular pressure of 18 mmHg or higher while on one or more topical IOP-lowering medications
- Open angle confirmed by gonioscopy
- Clear cornea and healthy ocular surface
- Able to give informed consent and willing to follow the study procedures
- Visual field loss consistent with glaucoma as confirmed by reproducible defects on two consecutive tests
- Healthy, mobile conjunctiva in the target eye's superior bulbar region
- Best-corrected visual acuity of 20/100 or better
- Visual field mean deviation no worse than -18.0 dB without dense paracentral scotomas
- No expected need for other eye surgeries within 3 months after enrollment
You will not qualify if you...
- Prior glaucoma filtering surgery like trabeculectomy, shunt, or valve in the treatment area
- Angle-closure, neovascular, uveitic, or traumatic glaucoma
- Conjunctival scarring or prior conjunctival surgery in the target eye quadrant
- Scleral thinning, staphyloma, or structural abnormalities in the treatment quadrant
- Uncontrolled intraocular pressure above 35 mmHg at screening
- Active eye infection or inflammation such as blepharitis, conjunctivitis, keratitis, or uveitis
- Active or recent iris neovascularization within the treatment quadrant
- Impaired episcleral venous drainage
- Presence of anterior chamber intraocular lens
- Uncontrolled bleeding disorders or anticoagulation therapy without proper management
- Advanced glaucomatous optic nerve damage
- Fuchs endothelial dystrophy with signs of endothelial failure
- Central corneal thickness greater than 600 micrometers
- Pathological myopia
- Inability to comply with follow-up or treatment instructions
- Women who are pregnant, nursing, planning pregnancy, or of childbearing potential without reliable contraception use as specified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (surgery day)
Participants undergo treatment with the Hexiris Microinvasive Scleral Trephine (MIST) device, a minimally invasive surgical procedure to reduce intraocular pressure in the affected eye, performed under topical anesthesia.
1 visit (in-person surgery)
Duration - Up to 1 week after surgery
Participants receive postoperative care including topical antibiotics and steroids to support healing after the MIST device implantation.
Visits on Day 1 and Week 1 (in-person)
Duration - 12 months post treatment
Participants have follow-up visits to monitor intraocular pressure, assess safety, and evaluate treatment success for 12 months after the procedure.
Regular visits at Weeks 1, Months 1, 2, 3, 6, 9, and 12 (in-person)
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.
E
elodie chamberland, BSN RN
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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