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Can a new lens design sharpen vision after macular surgery?

NCT ID NCT07789249

Symptom relief Sponsor: Almaviva Sante Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether an extended depth of focus (EDOF) lens, which aims to improve vision at multiple distances, works better than a standard monofocal lens in people who need both cataract and epiretinal membrane surgery. The study enrolls 100 adults with an epiretinal membrane and cataract. Participants receive one of the two lenses during surgery, and researchers measure visual acuity and patient-reported vision quality over six months.

What this could mean

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

Active substance
Two types of intraocular lenses: TECNIS monofocal and PureSee EDOF (extended depth of focus), implanted during cataract surgery.
What this could lead to
If EDOF lenses prove safe and effective in people with epiretinal membranes, they could offer better vision at multiple distances after combined cataract and macular surgery.
What could go wrong
The trial is relatively small and early, and EDOF lenses may still cause visual disturbances or not improve outcomes enough to justify their use in this specific patient group.

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 100 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

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: * Male or female over 18 years of age * Epiretinal membrane with surgical indication * Indication for cataract surgery with intraocular lens implantation * Epiretinal membranes with near visual acuity ≥ P4 * Preserved ellipsoidal zone in the retrofoveal region, without fragmentation or interruption * Central macular thickness less than or equal to 450 microns * Signed informed consent * Patients covered by social security or an equivalent scheme Exclusion Criteria: * Associated ocular pathologies (advanced glaucoma, exudative AMD). * Central macular thickness \> 450 microns * Epiretinal membranes with near visual acuity \< P4 * Previous macular surgery * Contraindication to the implantation of either type of lens * Cognitive impairment, or a disorder causing difficulty understanding instructions or answering questionnaires * Pregnant, parturient, or breastfeeding women, as defined in Article L1121-5 of the French Public Health Code (CSP) * Protected individuals: adults under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision. * Patients incapable of personally giving consent, as defined in Article L.1121-8 of the French Public Health Code (CSP), or adults protected by law

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Conditions

The condition(s) this trial relates to.

cataract preretinal fibrosis

As listed by the trial registrant

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

Extended depth of focus Intraocular implants

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 Monticelli Paradis

    Marseille, 13008, France

  • Clinique du Val d'Ouest - Centre Pôle Vision

    Aix-en-Provence, 13097, France

  • Clinique du Val d'Ouest - Centre Pôle Vision

    Écully, 69130, France

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