RecruitingNAINTERVENTIONAL

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

This study is looking at a new treatment for primary open-angle glaucoma (POAG), a common eye condition. If you're over 40 and your eye pressure isn't controlled with drops, this study might be for you. It's testing a small device called MIST to see if it can safely lower the pressure inside your eye. This is important because high eye pressure can damage your sight. Doctors will perform the procedure and then monitor your eye pressure and general eye health through several check-ups over a year. The goal is to find out if this new device is a good and safe way to help people with glaucoma.

At a glance

Status

Recruiting

Phase

Sponsor

Hexiris Inc

Enrolment target

Start

15 Jan 2026

Estimated completion

15 Mar 2027

Primary Open Angle Glaucoma

What is this study about?

This study is about a common eye condition called primary open-angle glaucoma (often shortened to POAG). With POAG, the pressure inside your eye slowly builds up. If this pressure stays too high, it can damage the nerve that connects your eye to your brain, which can lead to problems with your vision. Usually, doctors try to control this pressure with eye drops. But for some people, eye drops aren't quite enough.

That's where this study comes in. It's looking at a new, small device called the Hexiris MIST system. MIST stands for Microinvasive Scleral Trephine, which just means it's a very tiny tool that helps create a pathway for fluid to drain from your eye, thereby lowering the pressure. The main goal of this study is to see if using the MIST device can effectively and safely reduce the pressure inside the eye for people who haven't had enough success with eye drops alone.

The study will carefully follow people who get the MIST device over a year to make sure it's working well and that there are no unexpected problems. This research is important because it could lead to another treatment option for people living with glaucoma, helping to protect their vision for longer.

Key takeaways

Tests a new device (MIST) for glaucoma (POAG).
Aims to lower eye pressure when drops aren't enough.
For adults aged 40 and over.
Involves a single procedure on one eye.
Requires follow-up visits for 12 months.
Could offer a new way to manage glaucoma.

Who may be eligible?

To join this study, you need to be an adult aged 40 or older with a specific type of glaucoma called primary open-angle glaucoma (POAG). Your eye pressure must still be too high (at least 18 mmHg) even though you're using eye drops. Doctors will also check that your eye is generally healthy, with clear vision and no other major eye problems.

There are also some reasons why you might not be able to join. For example, if you've already had certain types of glaucoma surgery, or if you have other eye conditions like severe infections or scarring. Also, if your eye pressure is extremely high (above 35 mmHg) or if you have a condition that makes bleeding more likely, this study might not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Do you have primary open-angle glaucoma (POAG)?
Is your eye pressure still high (18 mmHg or more) even though you use eye drops?
Have you *not* had previous glaucoma filtering surgery on the treated eye?
Are you able to attend follow-up appointments for a year?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll have one eye treated with the MIST device. This procedure will take place either in an operating room or in a special clinic room, depending on how the early stages of the study go. Before the treatment, your eye will be numbed with drops, and a small amount of medicine called mitomycin C will be used alongside the MIST device. After the procedure, you'll use antibiotic and steroid eye drops for a while.

You'll need to attend several follow-up appointments over one year. These visits are usually the next day, then one week later, and then at one, two, three, six, nine, and twelve months after your treatment. During these appointments, the eye doctor will carefully check your eye, measure the pressure inside it, and ask you about how you're feeling. The total duration of your active participation will be 12 months.

Potential risks and benefits

Participating in this study might offer a potential benefit of lowering your eye pressure, which could help protect your vision if current eye drops aren't enough. However, like any medical procedure, there are potential risks, such as infection, bleeding, irritation, or other issues related to the surgery or the medications used. Your doctor will explain all known risks to you. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (5)

Eye Care Centre NB
Verified postcode
Dieppe, Canada· Recruiting
Miramichi EyeNB & Surgical Centres of Excellence
Verified postcode
Miramichi, Canada· Recruiting
Prism Eye Institute Inc.
Verified postcode
Brampton, Canada· Recruiting
Institut de l'oeil des Laurentides
Verified postcode
Boisbriand, Canada· Recruiting
Ophthalmology Clinic Bellevue
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is glaucoma?

Glaucoma is an eye condition where the pressure inside your eye becomes too high, which can damage the nerve connecting your eye to your brain and potentially affect your sight.

What is the MIST device?

The MIST device is a new, small medical tool designed to help lower eye pressure by improving the drainage of fluid from your eye.

Will the procedure hurt?

Your eye will be numbed with special drops before the procedure, so you shouldn't feel pain during the treatment. You might feel some discomfort afterwards, which your doctor can help manage.

How long will I be followed after the treatment?

You will have regular check-ups for 12 months after your eye is treated with the MIST device.

Can I still take my regular eye drops?

This will be discussed with you by the study doctor. For this study, you must be on at least one eye drop treatment that isn't fully controlling your eye pressure.

How to find out more

edouard Al Chami, M.Sc.

ealchami@triplehair.ca 6474533253 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.