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Can AI protect Kids' eyesight where eye doctors are scarce?

NCT ID NCT07825428

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing whether an artificial intelligence tool can sort children by their risk of nearsightedness and guide personalized prevention, such as more outdoor time and special glasses. The trial enrolls about 1,600 students in grades 1 through 3 from public primary schools in remote counties of Guizhou and Yunnan, China. Schools are randomly assigned to either the AI-guided approach or the usual screening and referral. Over 12 months, the study tracks changes in eye length and vision to see if the AI strategy works better and is worth the cost.

What this could mean

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

Active substance
an AI-based risk-stratified intervention strategy that combines outdoor activity guidance and defocus spectacle lenses
What this could lead to
If it works, this approach could give schools in remote areas a practical way to identify children at risk of myopia and slow its progression without needing specialized eye exams.
What could go wrong
The trial relies on AI risk predictions and behavior changes, which may not translate into meaningful protection for every child. Results from rural China may not apply to other settings, and the 12-month follow-up is too short to show long-term effects on 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

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 1,600 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

Oct 2027

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 9 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.

1. School level: Inclusion Criteria: * The school is a regular public primary school located within a project county in Guizhou Province or Yunnan Province. * The school has the organizational capacity to conduct myopia screening and follow-up studies in children and adolescents, including the ability to coordinate screening organization, parent communication, informed consent collection, result feedback, and follow-up coordination. * The number of students in grades 1-3 in study school is sufficient to meet the requirements for conducting a cluster randomized study. Exclusion Criteria: * The school has implemented a similar systematic myopia intervention program within the past year that may affect the evaluation of study outcomes. * Student mobility is high, with a predicted high risk of transfer, missed visits, or loss to follow-up within 12 months. * There is a lack of accessible medical institutions near the school to support necessary cycloplegic examinations and related services. 2. Participant level: Inclusion Criteria: * Age of participants is 6-9 years (equivalent to grades 1-3 of primary school). * Participants can be able to complete baseline and follow-up examinations including visual acuity, non-cycloplegic autorefraction, and axial length measurements. * For participants who have previously received myopia control interventions such as low-dose atropine eye drops, defocus spectacle lenses, or red-light therapy, a washout period of at least 1 month is required prior to enrollment. Exclusion Criteria: * Baseline spherical equivalent refraction (SER) ≤ -10.00 D. * Presence of ocular or systemic diseases (including infections) that may affect visual acuity or refraction, or use of systemic or topical medications that may alter ocular status or affect ocular health. * Presence of any ocular conditions that preclude suitability for the interventions in this study, including but not limited to amblyopia, manifest strabismus, or current use of orthokeratology lenses. * Presence of any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

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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

    3 sites. 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 & Treatment Center

    Shanghai, Shanghai Municipality, 200041, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000, China

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000, China

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