RecruitingNAINTERVENTIONAL

Cataract Surgery in Conjunction With Ab-interno Canaloplasty Compared to Cataract Surgery Only in Patients With Mild to Moderate Primary Open-Angle Glaucoma

This research study is for people who have both cataracts and a common type of glaucoma called primary open-angle glaucoma. The study wants to see if adding a new procedure, called 'ab-interno canaloplasty' using a special device, to standard cataract surgery works better than just having cataract surgery by itself. Both treatments aim to improve your vision due to cataracts. For your glaucoma, the canaloplasty procedure helps improve how fluid drains from your eye, which can lower your eye pressure. The study will follow participants for two years to see how well each approach works and if combining the treatments offers additional benefits for your eye health.

At a glance

Status

Recruiting

Phase

Sponsor

Nova Eye, Inc.

Enrolment target

Start

08 Sep 2022

Estimated completion

01 Jul 2027

Primary Open Angle Glaucoma

What is this study about?

This study is designed for individuals who have two common eye conditions: cataracts and a type of glaucoma called primary open-angle glaucoma. Cataracts cause cloudy vision, and surgery helps to replace the cloudy lens with a clear one, improving your sight. Glaucoma, on the other hand, is a condition where the pressure inside your eye can build up, potentially damaging the nerve that connects your eye to your brain. This can lead to vision loss if not managed.

The main goal of this study is to compare two ways of treating these conditions. One group of participants will receive standard cataract surgery. The other group will have cataract surgery combined with a newer procedure called 'ab-interno canaloplasty' using a specific device. This canaloplasty procedure is designed to improve the natural drainage system of your eye, which can help lower the pressure inside your eye and manage your glaucoma more effectively. Researchers want to see if combining these two procedures offers better results for people with both conditions compared to just having cataract surgery alone.

The study will carefully follow everyone for two years. During this time, the medical team will monitor your eye pressure, vision, and overall eye health. By comparing the results from the two groups, doctors hope to learn if adding the canaloplasty procedure alongside cataract surgery is a more beneficial approach for patients with mild to moderate primary open-angle glaucoma, helping them maintain their vision and eye health in the long term.

Key takeaways

This study compares cataract surgery alone versus cataract surgery combined with a new glaucoma procedure.
It's for people aged 55 or over with both cataracts and mild to moderate primary open-angle glaucoma.
The new procedure, 'ab-interno canaloplasty', aims to improve eye fluid drainage and lower eye pressure.
Participants will be followed for two years to monitor results.
The goal is to see if combining treatments offers better long-term eye health benefits.

Who may be eligible?

This study is looking for people who are aged 55 or older and have both a cataract that is affecting their vision and a common type of glaucoma called mild to moderate primary open-angle glaucoma. You should already be using between one and four different eye drop medications to control your eye pressure, and your eye pressure should fall within a certain range.

You might not be able to join if you've had certain past eye treatments for glaucoma in the eye being studied. This includes various laser treatments, specific types of glaucoma drainage devices, or previous forms of canaloplasty or goniotomy. Also, if you have other specific types of glaucoma (like traumatic or severe cases), or are planning to have another eye pressure-lowering procedure at the same time as the cataract surgery in this study, you might not be eligible. This is to make sure the study can clearly see the effects of the specific treatments being tested.

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 55 years old or older?
Do you have a cataract that affects your vision?
Have you been diagnosed with mild to moderate primary open-angle glaucoma?
Are you currently using between 1 and 4 eye drops for your glaucoma?
Have you never had certain previous glaucoma eye surgeries or laser treatments?
Do you have good general health otherwise?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: one group will have cataract surgery combined with the 'ab-interno canaloplasty' procedure, and the other group will have cataract surgery only. Neither you nor your regular eye doctor will know which group you are in, though the surgeons will be aware of the procedure they are performing. After your surgery, you will have several follow-up appointments over two years to check your eye health, vision, and eye pressure. You will continue to use any prescribed eye medications as advised by the study doctors. The total duration of your participation in the study will be 24 months, which is two years.

Potential risks and benefits

Taking part in this study might offer a potential benefit of better management of your glaucoma in addition to improving your vision from cataract surgery, especially if you receive the combined treatment. However, all surgeries carry some risks, such as infection, bleeding, or other complications, and the new procedure also has its own potential risks which your doctor will explain. There is no guarantee that either treatment will be successful for everyone. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

Berkeley Eye Center
Verified postcode
Sugar Land, United States· Recruiting
University of Bonn Eye Clinic
Verified postcode
Bonn, Germany· Recruiting
Augencentrum Köln Ophthalmology
Verified postcode
Cologne, Germany· Recruiting
St. Johannes Hospital
Verified postcode
Dortmund, Germany· Recruiting

Common questions

What is 'ab-interno canaloplasty'?

It's a special procedure performed from inside the eye during cataract surgery that helps your eye's natural drainage system work better to lower eye pressure due to glaucoma.

Will I know which treatment I'm getting?

No, you won't know if you're getting just cataract surgery or the combined procedure. This is common in studies to ensure fair results.

How long will I be involved in the study?

You'll be followed for 24 months, which is two years, after your surgery to track your eye's progress.

What kind of glaucoma is this study for?

This study focuses on people with mild to moderate primary open-angle glaucoma – a common type of glaucoma.

Can I still take part if I've had previous eye treatments?

It depends on the specific treatment. Some previous glaucoma treatments might mean you can't join, so it's important to discuss your medical history with the study team.

How to find out more

Mike Pickrel

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

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