Testing Hexiris Microinvasive Scleral Trephine for primary open angle glaucoma
Official title: Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma
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
- 1 group
- Sites in Dieppe, Miramichi and 3 more cities
- Recruiting
Interventions
- Medical 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.
Canadian Sites (5)
5 of 5 recruiting
- Recruiting
Eye Care Centre NB
Dieppe, New Brunswick
- Recruiting
Miramichi EyeNB & Surgical Centres of Excellence
Miramichi, New Brunswick
- Recruiting
Prism Eye Institute Inc.
Brampton, Ontario
- Recruiting
Institut de l'oeil des Laurentides
Boisbriand, Quebec
- Recruiting
Ophthalmology Clinic Bellevue
Montreal, Quebec
Eligibility Criteria
See who this study is looking for31 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, willingness to participate in the trial, and adhering to follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →
- +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-enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
Exclusion
- −Angle-closure, neovascular, uveitic, or traumatic glaucoma.
- −Eyes with scleral thinning, staphyloma, or structural abnormalities in the treatment quadrant
- −Uncontrolled IOP \> 35 mmHg at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −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-upFollow-upContinued check-ins after the treatment part is finished.Read more → or treatment instructions
- −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.
- −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:
- −Prior glaucoma filtering surgery (trabeculectomy, shunt or valve) in the treatment quadrant
- −Eyes with conjunctival scarring, prior conjunctival surgery or other pathologies in the treatment quadrant
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Hexiris Microinvasive Scleral Trephine (MIST).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 25 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Month 6.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Intraocular pressure lowering — measured over change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Month 6.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07358650 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Hexiris Microinvasive Scleral Trephine (MIST)Device
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: change from baselineBaselineYour starting measurements, taken before treatment begins.Read more → to Month 6.
The study as a whole is currently expected to finish around 2027-03-15.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 25 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 5 locations, including: Dieppe, New Brunswick, Canada; Miramichi, New Brunswick, Canada; Brampton, Ontario, Canada; Boisbriand, Quebec, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.