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Can a nightly eye drop tame severe nearsightedness in kids?

NCT ID NCT04699357

Disease control Sponsor: Shanghai Eye Disease Prevention and Treatment Center Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tested three strengths of atropine eye drops (0.01%, 0.04%, and 0.1%) in 219 children with high myopia (severe nearsightedness). The goal was to see which dose best slows the worsening of vision and eye growth over two years. Children received one drop in each eye every night, and researchers tracked changes in prescription and eye length, as well as side effects and how well children tolerated the treatment.

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
What this could lead to
If successful, this could offer a simple, nightly eye drop treatment to slow worsening nearsightedness in children, reducing future eye health risks.
What could go wrong
This is a completed study, but results may not apply to all children. Side effects like light sensitivity or blurred near vision are possible with higher doses.

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

219 people

The number who actually took part.

Started

Jul 2021

Finished

Sep 2024

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: * At least one eye with cycloplegic optometric spherical equivalent of -5.00 to -10.00D and best corrected distant visual acuity of at least 0.5 and near visual acuity of at least 1.0, Titmus Stereo acuity ≤ 80 seconds, Vision with external occultation of ≤ 10 prismatic diopters , vision with internal occultation of ≤ 6-8 prismatic diopters, and astigmatism equal to or less than -2.50D; * Myopia progression greater than 0.5D in the past year; * Possess normal cognitive and verbal communication abilities to actively cooperate with the prescribed treatment; * Written informed consent from the guardian and the child. Exclusion Criteria: * Diseases of the study eye: keratitis, cone cornea, congenital cataract, glaucoma, fundus diseases; combined with inflammation of the anterior or posterior segment of the eye, such as acute conjunctivitis, iridocyclitis; * Systemic diseases affecting the use of drugs: albinism, epilepsy, severe psychoneurological disorders, congenital heart disease, cardiac arrhythmias; * Atropine allergy; * Very low birth weight less than 1500 g; * Previous treatment with anticholinergics including atropine within the previous 1 year, or use of OK lenses, multifocal soft lenses within 3 months; * Other conditions judged by the investigator to be unsuitable for participation in the trial.

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Conditions

The condition(s) this trial relates to.

degenerative myopia

As listed by the trial registrant

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

High myopia

Contacts and locations

Locations

  • Shanghai Eye Disease Prevention & Treatment Center

    Shanghai, Shanghai Municipality, 200040, China

  • Shanghai General Hospital

    Shanghai, China

  • Shanghai Ninth People's Hospital

    Shanghai, China

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