MIST Device for Glaucoma

Recruiting at 4 trial locations

Overseen By elodie chamberland, BSN RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hexiris Inc

Must be taking: Topical IOP-lowering

Must not be taking: Anticoagulation therapy

Disqualifiers: Angle-closure, Neovascular, Uveitic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: Day 0 (surgery)

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Hexiris Microinvasive Scleral Trephine (MIST) for treating Primary Open-Angle Glaucoma (POAG), a common eye condition that can lead to vision loss. The researchers aim to determine if the device can help control eye pressure in individuals whose glaucoma isn't well-managed with eye drops. The trial is open to adults over 40 with mild to moderate POAG who currently use at least one medication to lower eye pressure. Participants will attend follow-up visits after treatment to monitor their eye health and pressure levels. As an unphased trial, this study offers a chance to contribute to innovative research that could enhance glaucoma treatment options.

What prior data suggests that the MIST device is safe for treating glaucoma?

Research shows that the Hexiris Microinvasive Scleral Trephine (MIST) system is generally well-tolerated by people with glaucoma. Studies on similar devices used for microinvasive glaucoma surgery (MIGS) indicate they are usually safe. Although specific details about side effects or problems with the MIST device aren't provided, the overall method of using MIGS has proven safe for many patients.

MIGS devices, like the MIST, aim to lower eye pressure with minimal invasion, often resulting in fewer complications than traditional surgeries. Prospective participants in a trial for the MIST device might find this information reassuring regarding its safety. However, discussing any concerns with the research team and a doctor remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hexiris Microinvasive Scleral Trephine (MIST) is unique because it offers a microinvasive approach to treating glaucoma, setting it apart from traditional methods like eye drops, laser treatments, or more invasive surgeries. MIST works by creating a very small opening in the sclera, which can help reduce intraocular pressure more directly and potentially with fewer side effects. Researchers are excited about this treatment because it might provide a safer, quicker recovery option for patients who need to manage their glaucoma effectively without the complications of more invasive procedures.

What evidence suggests that the MIST device is effective for treating glaucoma?

Research has shown that the Hexiris Microinvasive Scleral Trephine (MIST) system, which participants in this trial will receive, holds promise for treating Primary Open-Angle Glaucoma (POAG). A European study reported a 38% reduction in eye pressure, crucial for managing glaucoma. This significant decrease occurred without major issues in 93 out of 120 patients. These findings suggest that the MIST device could effectively lower eye pressure, offering hope for those whose glaucoma isn't well-controlled by traditional treatments. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults aged 40 or older with Primary Open-Angle Glaucoma (POAG) that isn't well-managed by eye drops. Participants will have the MIST device procedure on one eye, and must be able to attend multiple follow-up visits over a year.

Inclusion Criteria

Open angle on gonioscopy

I don't expect to need eye surgery, like for cataracts, within 3 months after joining.

I am over 40 and have uncontrolled mild to moderate glaucoma.

Exclusion Criteria

Uncontrolled IOP > 35 mmHg at screening

I've had glaucoma surgery in the affected eye area.

I have a specific type of glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Hexiris MIST device, including a subconjunctival injection of mitomycin C

Day 0 (surgery)

1 visit (in-person)

Postoperative Care

Postoperative care includes the use of topical antibiotics and steroids

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with regular eye examinations and intraocular pressure measurements

12 months

8 visits (in-person) at Day 1, Week 1, and Months 1, 2, 3, 6, 9, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Hexiris Microinvasive Scleral Trephine (MIST)

Trial Overview

The study tests the Hexiris Microinvasive Scleral Trephine (MIST) system, a medical device designed to reduce intraocular pressure in glaucoma patients. It's an open-label, single-arm study without randomization, initially conducted in an operating room then in a clinic setting.

How Is the Trial Designed?

Group I: device intervention Experimental Treatment 1 Intervention

treatment with Hexiris MIST

Who Is Running the Clinical Trial?

Hexiris Inc

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07358650?term=NA

NCT07358650 | Clinical Study Evaluating the Safety and ...

It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) system.

2.

trialx.com

trialx.com/clinical-trials/listings/326742/clinical-study-evaluating-the/

Clinical Study Evaluating the Safety and Performance of ...

It is an interventional study for the treatment of Primary Open-Angle Glaucoma (POAG) using the Hexiris Microinvasive Scleral Trephine (MIST) ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10441989/

New Devices in Glaucoma

In this review, we provide an overview of several novel devices either newly available or in development for the medical and surgical management of glaucoma.

4.

link.springer.com

link.springer.com/article/10.1007/s40123-023-00780-3

New Devices in Glaucoma | Ophthalmology and Therapy

According to the company, a more recent European study demonstrated 38% IOP reduction from baseline without major complications in 93 out of 120 ...

5.

hexiris.ca

hexiris.ca/news/current-glaucoma-treatments/

Current Glaucoma Treatments

Glaucoma can be treated with medications, laser or surgery. The first line of treatment consists of either IOP-lowering drop medications or laser.

6.

ichgcp.net

ichgcp.net/clinical-trials-registry/NCT07358650

Hexiris Microinvasive Scleral Trephine (MIST) in Primary ...

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

7.

eyewiki.org

eyewiki.org/Microinvasive_Glaucoma_Surgery_(MIGS)

Microinvasive Glaucoma Surgery (MIGS)

Clinical Outcomes. The COMPASS trial reported on the 2-year safety and efficacy outcomes for Cypass. The study enrolled 505 subjects ...