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

Project on Myopia Surveillance and Intervention Services for Preschool Children in Shanghai

This project will try spectacle lenses with highly aspherical lenslets and low-dose (0.01% and 0.05%) atropine eye drops to see if they slow myopia progression in children aged 3–6.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 508 (estimated)
• Ages: 3 Years to 6 Years
• Sex: All
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07176949 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 3–6 with early or pre-myopia (cycloplegic spherical equivalent up to +0.75 D), low astigmatism, good corrected visual acuity, and ability to wear spectacles and attend follow-up visits.

Not a fit: Children with strabismus, amblyopia, other ocular or systemic diseases affecting vision, or those who have recently used other myopia-control treatments are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, these interventions could slow progression to higher myopia in preschool children and reduce their lifetime risk of severe vision problems.

How similar studies have performed: Previous studies in older children have shown that defocus-type lenses and low-dose atropine can slow myopia, but evidence is limited for preschool-aged children.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Xiangui He, Prof

Conditions Myopia; Pre-myopia