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Eye drops may stop kids from becoming nearsighted

NCT ID NCT07449247

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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 233 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 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.

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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