Preventing early childhood myopia with special spectacle lenses and low-dose atropine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children aged 3–6 with early or pre-myopia will be enrolled and assigned to receive either spectacle lenses with highly aspherical lenslets or low-concentration atropine eye drops (0.01% or 0.05%). Vision and eye health, including cycloplegic refraction and other standard measures, will be monitored at regular visits to track refractive change and any side effects. Participants must be able to wear spectacles as required and attend follow-up visits at the study site. Outcomes will compare how much myopia progresses and the safety profile across the intervention groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 3-6 years, gender unrestricted;
* Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D;
* Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6;
* Accept regular follow-up, written informed consent from guardians, verbal informed consent from children;
* Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required.

Exclusion Criteria:

* Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery;
* Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.);
* Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks;
* Allergy or contraindication to cycloplegic drugs;
* Epilepsy or other mental disorders unable to expressing consent;
* Other conditions deemed unsuitable for participation by the researcher.

Where it's running

• Shanghai Eye Disease Prevention and Treatment Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiangui He, Prof
• Email: xianhezi@163.com
• Phone: +86 15000755422

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.