Hexiris MIST device to lower eye pressure in people with primary open-angle glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, non-randomized single-arm study using the Hexiris Microinvasive Scleral Trephine (MIST) system to create a controlled scleral opening and reduce intraocular pressure. Adults 40 years and older with POAG inadequately controlled on topical medications will have one eye treated; the first five cases are performed in the operating room and the next 20 at a slit-lamp in an aseptic clinic setting. Treatment includes the MIST device plus a subconjunctival mitomycin C injection, with standard postoperative topical antibiotics and steroids. Participants return for scheduled IOP and safety checks the next day, at 1 week, and at 1, 2, 3, 6, 9 and 12 months after treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Eye Care Centre NB
  Dieppe, New Brunswick, Canada Recruiting
• Miramichi EyeNB & Surgical Centres of Excellence
  Miramichi, New Brunswick, Canada Recruiting
• Prism Eye Institute Inc.
  Brampton, Ontario, Canada Recruiting
• Institut de l'oeil des Laurentides
  Boisbriand, Quebec, Canada Recruiting
• Ophthalmology Clinic Bellevue
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: edouard Al Chami, M.Sc.
• Email: ealchami@triplehair.ca
• Phone: 6474533253

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.