New glasses aim to stop kids from becoming nearsighted
NCT ID NCT06860737
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether special glasses can prevent nearsightedness (myopia) in children aged 6 to 9 who are not yet nearsighted but are at risk. About 388 children will wear the glasses for at least 8 hours a day for one year. Researchers will track how many children become nearsighted and measure changes in their eyes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- novel plano spectacle lenses
- What this could lead to
- If successful, these glasses could offer a simple, non-invasive way to prevent myopia in children, reducing the need for stronger prescriptions later.
- What could go wrong
- This is a single study with 388 children, and results may not apply to all kids. The lenses require consistent daily wear, and long-term benefits beyond one year 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
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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
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About 388 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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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
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6 to 9 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 the time of signing the informed consent form, the subject's age must be ≥6 years and \<10 years (6-9.99 years); * Both eyes are not myopic (SE\>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D\< SE under cycloplegia ≤+0.75D); \[spherical equivalent (SE)=Sph+Cyl/2\] * Astigmatism ≤1.00D in each eye; * Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D; * Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ; * Be in good general health; * Be able to actively cooperate with the intervention plan and ophthalmological examination; * Normal binocular vision * At least one parent with SER ≤-3.00 D Exclusion Criteria: * Incapable of expressing consent * All categories of persons particularly protected by law * Subject in another study which might have an influence on vision or interfere with study assessment. * Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months; * History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery; * Those who are allergic cycloplegic drugs; * Other reasons that the investigator considers inappropriate for inclusion 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.
Contacts and locations
Locations
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Xiangui He
Shanghai, 200040, China