Myopia control for kids using defocus lenses with ear acupressure in school

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

This is a school-based randomized trial in grades 1 to 4 that compares defocus spectacle lenses alone versus defocus lenses plus auricular acupressure for myopia control in children with premyopia or myopia. Participants are randomly assigned within their school and will undergo baseline and 12-month follow-ups, with a mid-study visit at 6 months. Outcomes include axial length changes, refractive error, adherence to the interventions, and safety. The study is conducted at a single center in Shanghai and is led by the Shanghai Eye Disease Prevention and Treatment Center. Enrollment requires parental consent and child assent, and excludes children with ocular or systemic conditions that could affect participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Students in grades 1 to 4 from participating primary schools.
* Children with premyopia or myopia at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D for premyopia, or less than or equal to -0.50 D for myopia.
* Written informed consent provided by a parent or legal guardian, and age-appropriate assent obtained from the child when applicable.
* Willingness to participate in baseline and follow-up assessments during the study period.

Exclusion Criteria:

* Strabismus, amblyopia, or other ocular abnormalities.
* Systemic disease or other medical conditions that may affect study participation.
* Has received any myopia prevention intervention in the past 3 months.
* Known skin sensitivity, local ear skin lesions, or other conditions judged unsuitable for auricular acupressure.
* Any other condition judged by the study doctors to make participation inappropriate.

Where it's running

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

Study contacts

• Study coordinator: Xiangui He, PhD
• Email: xianhezi@163.com
• Phone: +86 021-62717733

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Hyperopic reserve screening for kindergartners in Beijing

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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.