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New lens aims to sharpen vision at all distances after cataract surgery

NCT ID NCT06446817

Disease control Sponsor: Cutting Edge SAS Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new multifocal lens (LuxHighAdd) for cataract surgery, comparing it to a standard monofocal lens. About 57 people aged 50+ with cataracts in both eyes will receive the lens in both eyes. The goal is to see if the new lens improves near vision without harming distance vision.

What this could mean

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

Active substance
multifocal intraocular lens (LuxHighAdd IOL)
What this could lead to
If successful, this lens could help people see clearly at multiple distances after cataract surgery, reducing the need for glasses.
What could go wrong
This is a small, early-stage trial with only 57 people. The lens may not provide better vision than standard lenses, and risks like glare or halos are possible.

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 57 people

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

Started

Dec 2024

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

50 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: * Subject aged 50 or over on the day of inclusion, presenting a bilateral cataract, qualified for bilateral implantation * No ocular comorbidity possibly affecting the study results * Fit within the available IOL diopter range * Have had no previous refractive surgery * Regular corneal astigmatism ≤1.0 dioptres * Clear intraocular media other than cataract * Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Ability to attend all study follow-ups * Signed informed consent. Exclusion Criteria: * Ocular surface disease potentially affecting study results * Pre-existing ocular pathology or history of pathology potentially affecting the study results * Acute or chronic disease or illness that would increase risk or confound study results * Subjects who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than YAG capsulotomy) * Axial lengths and keratometry such as the IOL spherical power is not in the range of 16 to 26 D * Instability of keratometry or biometry measurements * Traumatic cataract * Amblyopia * History of ocular trauma or any prior ocular surgery including refractive procedures * Capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens * Pupil abnormalities * Systemic or ocular medication that could modify pupil dynamics * Expected complicated surgery or complicated surgery * Concurrent participation in another drug or device investigation

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Conditions

The condition(s) this trial relates to.

cataract

As listed by the trial registrant

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

Cataract

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Centre d'Ophtalmologie des Dr Rozot et associés

    RECRUITING

    Marseille, 13008, France

  • Clinique Honoré Cave

    RECRUITING

    Montauban, 82000, France

  • Hôpital Fondation Adolphe de Rothschild

    RECRUITING

    Paris, 75019, France

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