Eye drops may stop kids from becoming nearsighted
NCT ID NCT07449247
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether low-dose atropine eye drops can prevent nearsightedness (myopia) in children aged 6 to 9 who are at risk. Over 12 months, children receive daily drops, with the dose adjusted based on how fast their eyes change. The goal is to find the best dose to keep their vision clear and avoid needing glasses.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 233 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
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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Accepted
You do not need to have the condition being studied to take part.
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: 1. A written informed consent form signed by the child and their legal guardian has been obtained. 2. Children aged 6 to 9 years (inclusive). 3. Equivalent spherical diopter of computerized refraction after bilateral ciliary muscle paralysis: 0D\<SE. The upper limit standards for SE are set as follows for different age groups: 6 years old: P25 = +1.13D,7 years old: P25 = +1.00D,8 years old: P25 = +0.88D,9 years old: P25 = +0.63D. 4. After bilateral ciliary muscle paralysis, the astigmatism detected by computerized refraction is ≤1.00D. 5. Anisometropia ≤1.5D. 6. No other organic lesions affecting visual acuity in both eyes. 7. Unaided visual acuity ≥0.8. 8. Ocular intraocular pressure (IOP) ≤21 mmHg. Exclusion criteria: 1. Subjects who may have ocular diseases affecting vision or refractive errors (such as lens damage diseases like cataract, glaucoma, macular degeneration, corneal lesions, uveitis, retinal detachment, severe vitreous opacity, etc.). 2. Systemic diseases: Immune system disorders, central nervous system diseases, Down syndrome, asthma, severe cardiopulmonary dysfunction, and a history of severe hepatic or renal dysfunction. 3. Bilateral or unilateral ocular involvement with dominant strabismus or any other pathological ocular changes or acute inflammatory eye diseases. 4. Patients who have undergone myopia control treatments, including pharmacological therapy (e.g., atropine or piperazine), orthokeratology, multifocal soft lenses, multifocal hard lenses, functional eyeglass frames, or red light therapy. 5. Exclude patients who have used drugs affecting efficacy evaluation (e.g., anticholinergic agents: atropine, piperazine; cholinergic agents: pilocarpine) for systemic or local use within the preceding 3 months. 6. Patients with hypersensitivity to atropine, cipretosil, or other drugs used in this study. 7. Exclude participants who have participated in other drug clinical trials within the past 3 months. 8. Other circumstances deemed unsuitable by the investigator. 9. Individuals with chronic mental disorders or psychiatric abnormalities. 10. Those with an adjustment range below 8D.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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