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Can eye drops and special glasses stop Kids' nearsightedness from getting worse?

NCT ID NCT06523504

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether low-dose atropine eye drops (0.02% or 0.04%) combined with special glasses (DIMS) can slow the progression of moderate to high myopia (nearsightedness) in children aged 6 to 12. About 410 children will be assigned to different treatment groups and followed for changes in eye length and prescription. The goal is to find a safe, effective way to control myopia and reduce future eye health risks.

What this could mean

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

Active substance
atropine eye drops (0.02% and 0.04%) and defocus incorporated multiple segments (DIMS) glasses
What this could lead to
If successful, this could offer a safe, non-surgical way to slow down worsening nearsightedness in children, reducing their risk of eye problems later in life.
What could go wrong
This is an early-phase trial (Phase 1/2) with a moderate number of participants. The treatments may not work better than existing options, and atropine can cause side effects like light sensitivity or blurry near vision.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 410 people

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

Started

Feb 2024

Expected to finish

Mar 2026

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

6 to 12 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: * School-age children aged 6 to 12 years (including boundary value) * Children with moderate or high myopia (subjective refraction after cycloplegia: -9.00D≤spherical equivalent (SE)≤-3.00D, with-rule astigmatism (C)≤2.00D, against-rule astigmatism (C)≤1.00D, anisometropia of both eyes≤2.50D) * Binocular best corrected visual acuity (BCVA)≥0.8 (five-point visual acuity 4.9) * Agree with the study scheme and sign the informed consent * Note: if both eyes meet the inclusion criteria, the eye with higher spherical equivalent is the study eye; if one eye meets the inclusion criteria, the eye is the study eye. Exclusion Criteria: * Used or currently using orthokeratology, multifocal contact lenses, defocusing framework lenses, atropine eye drops and other myopia control means in the past month; used red light treatment in the past * Children with obvious strabismus and amblyopia * With congenital eye disease, such as congenital cataract, congenital retinal disease * Secondary myopia (such as premature retinopathy or other eye diseases in infants and children caused secondary myopia), or myopia combined with systemic syndrome (such as Marfan syndrome) * Had internal eye surgery (such as cataract extraction, intraocular lens implantation, anti-glaucoma surgery, etc.) * Refractive medium opacity (such as corneal disease, crystal opacity, etc.) * Bnormal intraocular pressure and clinical significance (IOP \<10 mmHg or IOP \>21mmHg or binocular IOP difference ≥5mmHg) * Fundus chorioretinopathy (except for high myopia fundus degenerative changes) or other intraocular diseases * Optic nerve damage or congenital optic nerve dysfunction * Can not be regularly checked * The adjustment range is less than 8D or obvious near difficulties * Other reasons researchers think it is not suitable for inclusion in researchers

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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

  • Tianjin Medical University Eye Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 120120, China

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