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New device aims to tackle glaucoma during routine cataract surgery

NCT ID NCT04899063

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed trial tested the ELIOS System, a device used during cataract surgery to lower eye pressure in adults with mild-to-moderate open-angle glaucoma. The study enrolled 318 participants and measured how many achieved a 20% or greater drop in eye pressure without medication. If effective, the ELIOS System could help reduce the need for daily glaucoma drops.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ELIOS System (a device procedure performed during cataract surgery)
What this could lead to
If successful, this could offer a way to lower eye pressure and reduce the need for glaucoma medications in people having cataract surgery.
What could go wrong
This is a completed trial, but results are not yet widely published. The device is only tested in people with mild-to-moderate glaucoma and may not work for everyone. Risks include possible side effects from the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

318 people

The number who actually took part.

Started

May 2021

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of mild to moderate POAG * Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse * Medicated IOP of \<=24 mmHg * Unmedicated diurnal IOP of \>=22 mmHg and \<=34 mmHg * Shaffer angle grade of III or IV * CD ratio \<=0.8 * At least 45 years old Exclusion Criteria: * Closed-angle and secondary glaucomas * Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery * Cannot undergo medication washout in the study eye * Diagnosis of degenerative visual disorders * Non-study eye with BCVA worse than 20/80 * Known corticosteroid responder * Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ELIOS Vision Clinical Site

    Glendale, Arizona, 85306, United States

  • ELIOS Vision Clinical Site

    Petaluma, California, 94954, United States

  • ELIOS Vision Clinical Site

    Fort Collins, Colorado, 80528, United States

  • ELIOS Vision Clinical Site

    Grand Junction, Colorado, 81501, United States

  • ELIOS Vision Clinical Site

    DeLand, Florida, 32720, United States

  • ELIOS Vision Clinical Site

    Largo, Florida, 33770, United States

  • ELIOS Vision Clinical Site

    Melbourne, Florida, 32904, United States

  • ELIOS Vision Clinical Site

    Vero Beach, Florida, 32960, United States

  • ELIOS Vision Clinical Site

    Rock Island, Illinois, 61201, United States

  • ELIOS Vision Clinical Site

    Overland Park, Kansas, 66213, United States

  • ELIOS Vision Clinical Site

    Chaska, Minnesota, 55318, United States

  • ELIOS Vision Clinical Site

    St Louis, Missouri, 63131, United States

  • ELIOS Vision Clinical Site

    Las Vegas, Nevada, 89145, United States

  • ELIOS Vision Clinical Site

    South Orange, New Jersey, 07079, United States

  • ELIOS Vision Clinical Site

    Oklahoma City, Oklahoma, 73112, United States

  • ELIOS Vision Clinical Site

    Duncanville, Texas, 75137, United States

  • ELIOS Vision Clinical Site

    El Paso, Texas, 79902, United States

  • ELIOS Vision Clinical Site

    San Antonio, Texas, 78229, United States

  • ELIOS Vision Clinical Site

    Kenosha, Wisconsin, 53142, United States

  • Elios Vision Clinical Site 2

    San Antonio, Texas, 78229, United States

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