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A monocentre, Single-Arm trial to study the effect of lens inspired by myopia control solutions on the astigmatism of a child

NCT ID NCT07810725

NEW Sponsor: Essilor International Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 09, 2026

Summary

The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism. The main question it aims to answer is: \- How does the eye respond at each timepoint to the myopia control lenses? By evaluating: the change in astigmatism (cylinder) after one year? Participants will: Wear the assigned study spectacles daily Visit the Essilor R\&D Centre for scheduled follow-up sessions

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 15 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

Mar 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

6 to 13 years

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: * Volunteer participant * Informed consent of parent or guardian and assent of participant * Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent. * Refractive error (manifest refraction): * With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°) * Astigmatism should be more than or equal to 1.50D * Least myopic meridian equal or less than -0.50D * Most myopic meridian equal or greater than -5.50D. * Anisometropia should be less than or equal to 1.00D * Best corrected visual acuity: Better than 0.2 logMAR in each eye * Willingness and ability to: * participate in trial for at least 12 months. * attend scheduled visits. * not to be involved in other myopia control treatments concurrently. * No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.) Exclusion Criteria: * History or presence of: * An ocular disease * Strabismus * Amblyopia

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Conditions

The condition(s) this trial relates to.

astigmatism myopia

As listed by the trial registrant

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

Astigmatism Myopia

How to take part

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  1. The official record

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

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