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New eye implant aims to ease glaucoma pressure without daily drops

NCT ID NCT05885022

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called the Calibreye System, a small implant placed in the eye to help drain fluid and lower pressure in people with open-angle glaucoma. Researchers will check if it is safe and works well over 12 months in 60 adults. The goal is to see if the device can reduce eye pressure and possibly cut down on the number of glaucoma medications needed.

What this could mean

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

Active substance
Calibreye System (glaucoma implant device)
What this could lead to
If successful, this device could offer a new way to lower eye pressure and reduce the need for daily eye drops in people with open-angle glaucoma.
What could go wrong
This is an early feasibility study with only 60 people, so results may not apply to everyone. The device may not lower pressure enough or could cause side effects like infection or implant failure.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Open angle, pseudoexfoliative or pigmentary glaucoma * IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg * Visual field mean deviation score of -3dB or worse * Area of healthy, free and mobile conjunctiva in the target quadrant * Shaffer angle grade ≥ 3 in the target quadrant Exclusion Criteria: * Angle closure glaucoma * Congenital, neovascular or other secondary glaucomas * Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring \> 3 months prior to the preoperative visit) * Previous glaucoma shunt/valve in the target quadrant * Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit * History of corneal surgery, corneal opacities or corneal disease * Active diabetic retinopathy

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Centro Oftalmologico de Chihuahua

    RECRUITING

    Chihuahua City, Mexico

  • Dr. Agarwal's Eye Hospital Ltd.

    ACTIVE_NOT_RECRUITING

    Chennai, 600018, India

  • Oftalmología Láser de Puebla S.C.

    RECRUITING

    Puebla City, 72540, Mexico

  • Panama Eye Center

    RECRUITING

    Panama City, Panama

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