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Can special glasses stop Kids' eyesight from getting worse?

NCT ID NCT05886348

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests whether new spectacle lenses can safely slow the progression of myopia (nearsightedness) in children. About 249 kids will wear either the novel lenses or standard single vision glasses for 36 months. Researchers will measure changes in eye length and prescription strength to see if the new lenses work better.

What this could mean

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

Active substance
Novel spectacle lenses (Model-A and Model-B)
What this could lead to
If successful, these lenses could offer a non-invasive way to slow down worsening nearsightedness in children, reducing the need for stronger prescriptions.
What could go wrong
This is a mid-sized trial, and results may not apply to all children. The lenses might not slow myopia better than standard glasses, and long-term effects are unknown.

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

249 people

The number who actually took part.

Started

Jul 2023

Expected to finish

May 2027

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

7 to 13 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: 1. Participant and parent (or guardian) are able and willing to provide consent 2. Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements 3. Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to 4. Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study 5. Age at time of parent or guardian consent and participant assent: 7 - 13 years old 6. Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye. 7. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye 8. Cycloplegic autorefraction anisometropia of 1.50 D or less 9. Monocular best corrected distance visual acuity (BCDVA) equal to or better than logMAR 0.10 in each eye. Exclusion Criteria: 1. Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops 2. Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development 3. (a) Have received treatment of myopic control pharmaceutical medication (e.g., atropine) or light fundus illuminance therapy (e.g., repeated red light therapy) within 6 months prior to entry into this study. (b) Have received treatment of myopia control such as contact lenses, orthokeratology lenses etc., progressive addition lenses, bifocal lenses, within 3 months. (c) Have received treatment of myopia control such as defocus spectacle lenses (difference between both eye's non-cycloplegic autorefraction and lens-meter results of the respective lenses are equal or less than 0.50 D SER) etc. within one month prior to entry into this study. 4. Participant with clinically significant strabismus (including intermittent tropia) 5. Medical history of binocular vision abnormalities 6. Participant with amblyopia 7. Participation in a clinical trial within 30 days prior to entry into this study or during participation 8. Previous intraocular surgery 9. Participant who, in the judgment of the Investigator, presence of any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment. 10. Any medical treatment or medication which might have an influence on vision or interfere with study assessments 11. Pathological myopia (myopia that leads to structural changes in the posterior segment of the eye including posterior staphyloma, myopic maculopathy, and high myopia-associated optic neuropathy)

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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.

Contacts and locations

Locations

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, China

  • Eye and ENT Hospital of Fudan University

    Shanghai, China

  • Guangzhou Aier Eye Hospital

    Guangzhou, China

  • Shengyang He Eye Specialist Hospital

    Shengyang, China

  • Tianjin Medical University Eye Hospital

    Tianjin, China

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