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Smart contact lens could help those with vision loss see better

NCT ID NCT06989658

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a miniaturized smart contact lens in 32 people—some healthy, some with Stargardt's disease—to see if it is comfortable and easy to use. The lens tracks eye movements to help with vision tasks. Researchers will check for side effects and ask participants how they liked the lens.

What this could mean

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

Active substance
miniaturized smart contact lens (scleral lens device)
What this could lead to
If successful, this could lead to a more comfortable and practical way for people with central vision loss to use eye-tracking technology, potentially improving daily activities.
What could go wrong
This is an early feasibility study with only 32 participants, so results may not apply broadly. The lens may cause discomfort or side effects, and it is not designed to treat or cure Stargardt's disease.

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 32 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Feb 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 to 70 years

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: Patients with Stargardt disease * Age: 18 - 70 ; * Juvenile form of Stargardt's disease manifested by decreased visual acuity; * Visual acuity greater than or equal to 20/400 in binocular vision; * MMSE score without visual item ≥ 20/25 ; * Eyes whose palpebral opening and ocular surface and its appendages allow the wearing of a scleral lens; * Sufficient knowledge of the French language. * Ability to give express, free and informed consent in person, after having received adequate information; * Ability to comply with protocol requirements; * Person covered by Health Insurance. Healthy volunteers: * Age: 18 - 70 years; * Age- and sex-matched healthy volunteers to subjects with Stargardt's disease (± 5 years); * MMSE score with visual items ≥ 25/30 ; * Eyes with palpebral opening and ocular surface and appendages suitable for scleral lens wear; * Visual acuity of at least 10/10 in binocular vision; * Sufficient knowledge of the French language; * Ability to give personal, express, written, free and informed consent after receiving adequate information ; * Ability to comply with protocol requirements; * Person covered by Health Insurance. Exclusion Criteria: For all participantsPersons referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons : pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or curatorship); * Participants with neurodegenerative diseases or any other disease that could interfere with the planned evaluations during this study; * Participants with ophthalmological diseases other than Stargardt's disease; * Participants with a history of cleft palate, corneal infection, irregular cornea (such as keratoconus) and severe dry eye syndrome as determined by the ophthalmologist; * Participants allergic or sensitive to methyl acrylic poly methacrylate (PMMA) or to any of the components of the Re-See lens; * Participants allergic to tropicamide, atropine or its derivatives * Participants at risk of angle-closure glaucoma; * Participants allergic to sodium fluorescein; * Suspicion of transmissible spongiform encephalopathy; * Medications that may cause motor, visual or cognitive disorders (neuroleptics, etc.) or that may interfere with study evaluations; * Participation in another clinical trial that could interfere with the present study; * Inability to follow instructions or read. ☞Wearing glasses or contact lenses is not a non inclusion criterion.

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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 places running it

    1 site. 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 Hospitalier National d'Ophtalmologie des Quinze-Vingts

    Paris, 75012, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.