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RecruitingNAINTERVENTIONAL

Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

This research study is for people who have both open-angle glaucoma and cataracts. Glaucoma is an eye condition that damages the optic nerve, often due to high pressure inside the eye. Cataracts cause cloudy vision. The study is comparing a new treatment called ELIOS against another standard device. Both treatments are used during cataract surgery. Researchers want to see which one is better at lowering the pressure in your eye 12 months after the operation, and how safe both options are. The goal is to find the most effective way to help patients with both these eye conditions improve their vision and eye health.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Elios Vision, Inc.
Enrolment target
194
Start
05 Dec 2023
Estimated completion
31 Mar 2028

What is this study about?

Imagine you're trying to see through a foggy window – that's a bit like having a cataract. At the same time, some people also have a condition called glaucoma, which can slowly damage the nerve that connects your eye to your brain, often because the pressure inside your eye is too high. This study is for people who have both these problems.

When doctors remove cataracts, they usually replace the cloudy lens with a new, clear one. This study is testing if adding a special tiny device during this surgery can also help with the glaucoma. They're comparing a newer device called ELIOS with another device that doctors sometimes use. The main goal is to figure out which of these devices does a better job of lowering eye pressure and keeping it down for at least a year after the surgery.

By carefully comparing these two methods, doctors hope to learn which approach is best for people with both glaucoma and cataracts. This research is important because it could lead to better treatments, helping people to see more clearly and protect their eyesight from glaucoma damage for longer.

Key takeaways

  • This study is for people with both open-angle glaucoma and cataracts.
  • It compares a new treatment (ELIOS) with another standard device during cataract surgery.
  • The main goal is to see which treatment lowers eye pressure better over 12 months.
  • It aims to find safer and more effective ways to manage both eye conditions.
  • Participation involves eye surgery and follow-up appointments for at least a year.

Who may be eligible?

To join this study, you need to be at least 40 years old and have a specific type of glaucoma called 'open-angle glaucoma', which isn't too severe. You also need to have cataracts that are affecting your vision and need to be removed.

There are some reasons why you might not be able to join. For example, if you have other types of glaucoma like 'angle-closure glaucoma', or if your glaucoma was caused by an injury, another illness, or certain medicines. Also, if you’ve had previous eye surgery for glaucoma, or certain laser treatments on your eye in the last six months, you won't be able to take part.

The study is open to both men and women.

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.

  1. Are you 40 years old or older?
  2. Do you have mild to moderate open-angle glaucoma?
  3. Do you have cataracts that affect your vision and need surgery?
  4. Have you NOT had previous glaucoma surgery or certain eye laser treatments in the last 6 months?
  5. Do you NOT have other specific types of glaucoma, like angle-closure glaucoma?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves isn't fully available in this brief summary. However, generally in studies like this, you would have an initial screening visit to check if you're suitable. If you are, you would then have your cataract surgery, where either the ELIOS device or the competitor device would be placed. You would then need to attend several follow-up appointments over a period of at least 12 months. These visits would likely include eye exams, eye pressure checks, and possibly other tests to monitor your progress and the effectiveness of the treatment.

Potential risks and benefits

Taking part could offer the benefit of receiving a new or established treatment for both your cataract and glaucoma, with close monitoring of your eye health. However, like any surgery, there are potential risks, such as infection, bleeding, or other complications related to eye surgery. There might also be specific risks associated with the devices being tested. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • ELIOS Clinical Site
    Verified postcode
    Leuven, Belgium· Recruiting
  • Elios Clinical Site
    Verified postcode
    Avranches, France· Recruiting
  • ELIOS Clinical Site
    Verified postcode
    Bordeaux, France· Recruiting
  • ELIOS clinical site
    Verified postcode
    Paris, France· Recruiting
  • ELIOS Clinical Site
    Verified postcode
    Bochum, Germany· Recruiting
  • Elios clinical site
    Verified postcode
    Bonn, Germany· Recruiting
  • ELIOS clinical site
    Verified postcode
    Heidelberg, Germany· Recruiting
  • ELIOS Clinical Site
    Verified postcode
    Maastricht, Netherlands· Recruiting
  • ELIOS clinical site
    Verified postcode
    Barcelona, Spain· Recruiting
  • ELIOS Clincal Site
    Verified postcode
    Madrid, Spain· Recruiting
  • ELIOS Clinical site
    Verified postcode
    Madrid, Spain· Recruiting
  • ELIOS Clinical Site
    Verified postcode
    East Grinstead, United Kingdom· Recruiting

Common questions

What is glaucoma?

Glaucoma is an eye condition that damages the nerve connecting your eye to your brain, often due to high pressure inside your eye. This can lead to vision loss if not treated.

What is a cataract?

A cataract is when the natural lens in your eye becomes cloudy, making your vision blurry, hazy, or yellowish. It's like looking through a frosted window.

What does 'open-angle glaucoma' mean?

This is the most common type of glaucoma where the drainage angle in your eye is open, but the fluid doesn't drain properly, causing pressure to build up slowly.

Will I know which device I get?

Often in studies like this, you won't know which device you receive (ELIOS or the competitor) to ensure the results are fair and unbiased. Your doctor may or may not know during the study.

How long will the study last for me?

The main part of the study measures how well the treatments work for 12 months after your surgery, so you would be followed for at least that amount of time.

How to find out more

Cameron Hudson

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

Interested in taking part?

Register your interest

Share your details and the research team for "Comparative Effectiveness and Safety of ELIOS in Patients Wi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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