Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma

January 14, 2026 updated by: Hexiris Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • New Brunswick
      • Dieppe, New Brunswick, Canada, E1A 9T8
        • Recruiting
        • Eye Care Centre NB
        • Contact:
      • Miramichi, New Brunswick, Canada, E1N 1B2
    • Ontario
      • Brampton, Ontario, Canada, L6Y 4M3
        • Recruiting
        • Prism Eye Institute Inc.
        • Contact:
    • Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: device intervention
treatment with Hexiris MIST
Device: 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.
Other Names:
  • subconjunctival mitomycin C injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraocular pressure lowering
Time Frame: change from baseline to Month 6
Mean reduction in IOP (Goldmann applanation tonometry)
change from baseline to Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Greater or equal to 20% reduction in intraocular pressure (IOP)
Time Frame: change from baseline to Months 6 and 12.
Proportion of patients achieving ≥20% IOP reduction
change from baseline to Months 6 and 12.
Surgical success
Time Frame: at Month 12
IOP 6-18 mmHg at Month 12 without additional surgery.
at Month 12
concomitant glaucoma medications
Time Frame: change from baseline at week 1 and Months 1, 2, 3, 6, 9 and 12.
Change in the number of glaucoma medications
change from baseline at week 1 and Months 1, 2, 3, 6, 9 and 12.
Composite surgical success
Time Frame: at Month 12
IOP ≤ 21 mmHg and ≥20% reduction at Month 12 without additional glaucoma surgery, or clinically significant hypotony.
at Month 12
Bleb morphology
Time Frame: at week 1 and Months 1, 2, 3, 6, 9 and 12.
Bleb morphology and stability - 4 point grading: healthy; injected; diffused bleb; others.
at week 1 and Months 1, 2, 3, 6, 9 and 12.
Corneal thickness
Time Frame: change from baseline to Month 6.
Central corneal thickness (CCT) changes
change from baseline to Month 6.
Complications
Time Frame: at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.
Incidence of conjunctival erosion, hypotony-related complications (reported separately as numerical hypotony [IOP ≤ 5 mmHg] and clinical hypotony with complications).
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.
Number of patients needing MMC injection after surgery.
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.
Number of MMC injections needed post op per patient.
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.
reporting of adverse events and serious adverse events
day of surgery and at Day 1, week 1 and Months 1, 2, 3, 6, 9 and 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hexiris Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 020-3028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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