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New contact lenses aim to stop kids from becoming nearsighted

NCT ID NCT07566234

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This study tests whether dual focus contact lenses can prevent myopia (nearsightedness) in children aged 8 to 10 who are at risk. Over 2 years, researchers will check if these lenses stop the onset of myopia compared to standard lenses. If it works, it could offer a simple way to protect children's vision.

What this could mean

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

Active substance
Dual-Focus Contact Lens
What this could lead to
If successful, these lenses could offer a simple way to prevent children from becoming nearsighted, reducing the need for glasses or stronger prescriptions later.
What could go wrong
This is a small, early-stage study with only 110 children, so results may not apply to everyone. The lenses might not prevent myopia as hoped, and there could be discomfort or eye health risks from wearing contact lenses at a young age.

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 110 people

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

Started

Jun 2026

Expected to finish

May 2029

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

8 to 10 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: 1. Male and female children aged between 8-10 years inclusive. 2. Cycloplegic SER from -0.25 (non-inclusive) to +0.75 D (inclusive) in both eyes. 3. Astigmatism ≤ -1.00D in both eyes. 4. Un-corrected visual acuity (UCVA) ≤ 0.1 LogMAR. 5. As applicable (dependent on local requirements), the subject and parent/legal guardian will have read the Informed Assent/Consent, been given an explanation of the study, indicated an understanding and signed the forms. 6. Along with their parent or guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to the instructions set forth in this protocol. 7. Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study. 8. Agree and able to wear the assigned contact lenses successfully for a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.) 9. Be in good general health, based on his/her and parent's/guardian's knowledge. 10. Any history of myopia control interventions with in 1 month must complete a 4-weeks of washout period. Exclusion Criteria: 1. History of myopia control intervention (e.g., atropine, orthokeratology, soft myopia control contact lenses, red light therapy, etc. over more than 1 month) 2. Currently wears rigid gas permeable contact lenses, including orthokeratology lenses. 3. Current use of systemic or ocular or medications which may affect contact lens wear, tear film production, pupil size, accommodation or refractive state. 4. Ocular or systemic disease that contraindicates contact lens wear. 5. Active allergic conjunctivitis. 6. Any ocular, systemic or neuro-developmental conditions that could influence refractive development. 7. Keratoconus or an irregular cornea. 8. History of clinically significant binocular vision abnormality or strabismus. 9. Any active anterior segment finding that would contraindicate contact lens wear. 10. The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.

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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

  • Shanghai Eye Disease Prevention and Treatment Center

    RECRUITING

    Shanghai, 200030, China

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