Primary Open Angle GlaucomaNCT07358650
Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
A study testing Hexiris Microinvasive Scleral Trephine (MIST) in people with Primary Open Angle Glaucoma, run by Hexiris Inc at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Hexiris Microinvasive Scleral Trephine (MIST)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesCanada
- Study dates
- 15 Jan 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Institut de l'oeil des Laurentides
Boisbriand, Quebec, J7H 0E8
Janik Denis, 450-419-6345 ext. 227, jdenis@institutdeloeil.com
Lisa Monteschio, 450-419-6345 ext. 263, lmonteschio@institutdeloeil.com
- Recruiting
Prism Eye Institute Inc.
Brampton, Ontario, L6Y 4M3
Mike Yang, MD, 905-456-3937 ext. 605, mike.yang@prismeye.ca
- Recruiting
Eye Care Centre NB
Dieppe, New Brunswick, E1A 9T8
Tatjana Lapierre, 506-830-1773 ext. 6, lapierre5783@gmail.com
- Recruiting
Miramichi EyeNB & Surgical Centres of Excellence
Miramichi, New Brunswick, E1N 1B2
Heather Hayne, 506-424-7086, heatherhayne.sh@gmail.com
Courtney Mcevoy, 506-625-4904, cournteymcevoy.sh@gmail.com
- Recruiting
Ophthalmology Clinic Bellevue
Montreal, Quebec, H1V 1G5
Nataliya Khrushch, 514-256-0007, nkhrushch@cliniquebellevue.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Hexiris Microinvasive Scleral Trephine (MIST)
- Keywords
- scleral trephine, surgical trabeculectomy, bleb-forming intervention
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexiris Microinvasive Scleral Trephine (MIST)Device
Also called subconjunctival mitomycin C injection
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.
| Study group | Role | What they receive |
|---|---|---|
| device intervention | Experimental | treatment with Hexiris MIST Receives: Device: Hexiris Microinvasive Scleral Trephine (MIST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure lowering
Mean reduction in IOP (Goldmann applanation tonometry)
Measured: change from baseline to Month 6
Secondary outcomes (10)
Greater or equal to 20% reduction in intraocular pressure (IOP)
Proportion of patients achieving ≥20% IOP reduction
Measured: change from baseline to Months 6 and 12.
Surgical success
IOP 6-18 mmHg at Month 12 without additional surgery.
Measured: at Month 12
concomitant glaucoma medications
Change in the number of glaucoma medications
Measured: 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.
Measured: at Month 12
Bleb morphology
Bleb morphology and stability - 4 point grading: healthy; injected; diffused bleb; others.
Measured: at week 1 and Months 1, 2, 3, 6, 9 and 12.
Corneal thickness
Central corneal thickness (CCT) changes
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: day of surgery and at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Jan 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, open-label, non-randomized, single-arm, first-in-human clinical study: MIST + MMC: Subconjunctival MMC (0.02-0.04%) MMC will be injected subconjunctivally using a sterile technique, either prior to or following the procedure, at the surgeon's discretion.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexiris Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358650
- Sponsor's protocol ID
- 020-3028
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07358650
- Acronym / sponsor ID
- 020-3028
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- scleral trephine, surgical trabeculectomy, bleb-forming intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hexiris IncIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, open-label, non-randomized, single-arm, first-in-human clinical study: MIST + MMC: Subconjunctival MMC (0.02-0.04%) MMC will be injected subconjunctivally using a sterile technique, either prior to or following the procedure, at the surgeon's discretion.
| Arm | Type | Receives |
|---|---|---|
| device intervention | Experimental | Device: Hexiris Microinvasive Scleral Trephine (MIST)treatment with Hexiris MIST |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hexiris Microinvasive Scleral Trephine (MIST)Also: subconjunctival mitomycin C injectionThe 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. | Device | device intervention |
Primary outcome
Intraocular pressure lowering
Time frame: change from baseline to Month 6
Mean reduction in IOP (Goldmann applanation tonometry)
10 secondary outcomes
Greater or equal to 20% reduction in intraocular pressure (IOP)
Time frame: change from baseline to Months 6 and 12.
Surgical success
Time frame: at Month 12
concomitant glaucoma medications
Time frame: change from baseline at week 1 and Months 1, 2, 3, 6, 9 and 12.
Composite surgical success
Time frame: at Month 12
Bleb morphology
Time frame: at week 1 and Months 1, 2, 3, 6, 9 and 12.
Corneal thickness
Time frame: change from baseline to Month 6.
Complications
Time frame: at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Patients requiring Mitomycin C post treatment
Time frame: at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Mitomycin C injection post treatment
Time frame: at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Safety - adverse events and device failures
Time frame: day of surgery and at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Primary Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hexiris Microinvasive Scleral Trephine (MIST) in people with Primary Open Angle Glaucoma, run by Hexiris Inc at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact edouard Al Chami, M.Sc. (6474533253, ealchami@triplehair.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure lowering (time frame: change from baseline to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.