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Tests treatment safety and results 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
ClinicalTrials.gov ID: NCT07358650
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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
You likely can't join if
- 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).
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Dieppe, New Brunswick, Canada
- Miramichi, New Brunswick, Canada
- Brampton, Ontario, Canada
- Boisbriand, Quebec, Canada
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dieppe, New Brunswick, Canada; Miramichi, New Brunswick, Canada; Brampton, Ontario, Canada; Boisbriand, Quebec, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.