RecruitingNAINTERVENTIONAL

Multicenter Glaucoma Study Investigating Standalone Canaloplasty

This study is looking at two types of keyhole surgery for a condition called primary open-angle glaucoma, which causes high pressure inside the eye. The surgery, called canaloplasty, aims to improve the eye's natural drainage system. Researchers want to see how effective two different devices, the iTrack Advance and the OMNI Surgical System, are at lowering eye pressure when used as the only treatment. They are comparing these two methods in people who have mild to moderate glaucoma and are either struggling with eye drop medicine or want to reduce how much they use. The goal is to find out which device might work better to keep eye pressure down.

At a glance

Status

Recruiting

Phase

Sponsor

Nova Eye, Inc.

Enrolment target

Start

09 May 2023

Estimated completion

01 Dec 2026

Primary Open Angle Glaucoma

What is this study about?

This study is focused on a common eye condition called primary open-angle glaucoma. This condition happens when the natural drainage system in your eye doesn't work as well as it should, leading to a build-up of fluid and increased pressure inside the eye. If this pressure stays high, it can damage the nerve that connects your eye to your brain, potentially affecting your vision.

In this study, doctors are looking at a type of keyhole surgery called canaloplasty. Think of your eye like a sink with a drain. With glaucoma, the drain, called Schlemm's canal, gets a bit blocked. Canaloplasty aims to gently open up this natural drain to help the fluid escape more easily, which can lower the pressure. The study is comparing two specific tools, the iTrack Advance and the OMNI Surgical System, that surgeons use to perform this canaloplasty procedure from inside the eye (ab-interno).

The main goal is to see which of these two devices is more effective when used as a standalone treatment – meaning it’s the only procedure done for glaucoma during that visit. They want to find out how well each device helps reduce eye pressure in people with mild to moderate glaucoma, especially if they're having trouble with their current eye drop medications or wish to use fewer of them.

Key takeaways

Compares two surgical devices for glaucoma.
Focuses on mild to moderate primary open-angle glaucoma.
Aims to lower eye pressure by improving natural drainage.
Looks at these surgeries as a single, standalone treatment.
May help reduce reliance on glaucoma eye drops.
Participation involves surgery and regular follow-up visits.

Who may be eligible?

This study is looking for adults aged 22 or over who have been diagnosed with mild to moderate primary open-angle glaucoma. You might be a good fit if your eye doctor thinks canaloplasty surgery would be suitable for you, and you're either finding it difficult to use your glaucoma eye drops or want to reduce the number of drops you take.

There are also specific measurements for your eye pressure and other eye features that need to be met. For example, your eye pressure needs to be within a certain range, both with and without your current eye drops. It's important that you're able to come to all the appointments and understand what's involved in the study.

You would not be able to join if you've had certain other glaucoma treatments or surgeries in the study eye, like specific laser treatments or other types of stents. If you have other kinds of glaucoma, such as those caused by injury, inflammation, or certain genetic conditions, or if you've had recent cataract surgery, you also wouldn't be able to participate.

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 22 years old or older?
Have you been diagnosed with mild to moderate primary open-angle glaucoma?
Are you a candidate for canaloplasty surgery?
Are you struggling with your current glaucoma eye drops or want to use fewer?
Have you not had certain other glaucoma surgeries or laser treatments recently in the eye being studied?
Can you attend all study appointments and follow-up visits?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have regular visits to the clinic for check-ups and eye measurements. You would receive one of the two canaloplasty surgical procedures, either using the iTrack Advance device or the OMNI Surgical System. These procedures are designed to be done as a standalone treatment for your glaucoma. You will need to attend all scheduled follow-up appointments after your surgery so that the doctors can carefully monitor your eye pressure and overall eye health. The total duration of your participation in the study, including all follow-up visits, would be explained to you in detail.

Potential risks and benefits

Participating in this study might offer you access to a new or different surgical approach for managing your glaucoma, potentially helping to lower your eye pressure and reduce your reliance on eye drop medications. However, as with any surgery, there are potential risks, including infection, bleeding, or other eye complications. The study team will explain all known risks associated with the surgery and study procedures. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Breyer Kaymak Klabe Augenchirurgie
Verified postcode
Düsseldorf, Germany· Recruiting
Hospital Clinico San Carlos, Servicio de Oftalmologia
Verified postcode
Madrid, Spain· Recruiting
Princess Alexandra Eye Pavilion, NHS Lothian
Verified postcode
Edinburgh, United Kingdom· Recruiting
St. Paul's Eye Unit, Liverpool University
Verified postcode
Liverpool, United Kingdom· Recruiting
Manchester Royal Eye Hospital
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is primary open-angle glaucoma?

It's a common eye condition where the drainage system in your eye doesn't work well, causing pressure to build up inside your eye, which can damage your optic nerve.

What is canaloplasty surgery?

It's a keyhole surgery designed to gently open up your eye's natural drainage channel (Schlemm's canal) to help fluid flow out and reduce eye pressure.

What are the iTrack Advance and OMNI Surgical System?

These are two different devices used by surgeons to perform the canaloplasty procedure from inside your eye to improve drainage.

Why is this study important?

This study aims to find out which of these two surgical devices is more effective at lowering eye pressure when used as the only treatment for mild to moderate glaucoma.

Will I still need eye drops after the surgery?

The goal of the surgery is often to reduce or eliminate the need for eye drops. However, whether you still need drops will depend on how well your eye pressure is controlled after the procedure.

How to find out more

Mike Pickrel

mpickrel@nova-eye.com 1-800-391-2316 Official trial record

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