School-based Myopia Prevention Trial for Children With Insufficient Hyperopic Reserve

NCT07746804 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Phase

Not applicable

Started

2026-06-01

Last updated

2026-08-05

Condition(s) studied

Refractive ErrorsHyperopiaMyopia

Investigational drug(s) / intervention(s)

Auricular AcupressureEye Health Education

Auricular Acupressure: Auricular acupressure will be performed using adhesive patches containing vaccaria seeds applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once weekly by trained medical personnel according to a standardized protocol. Each application will remain in place for 5 days, followed by a 2-day rest period, with the treated ear alternated weekly. Participants will be instructed to press the patches three times daily, in the morning, at noon, and before bedtime, with 10 to 20 presses each time. If patches fall off, loosen, or cause local discomfort, the school health teacher or study personnel will be informed and appropriate management will be provided.

Eye Health Education: Standard school-based eye health education will include general guidance on healthy visual behaviors, near-work habits, reading posture, lighting conditions, eye exercises, and regular eye examinations.

Study summary

This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure for myopia prevention in non-myopic primary school students with insufficient hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either an auricular acupressure intervention or usual daily activities without additional study-related myopia prevention intervention. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.

Eligibility

Sex

ALL

Min age

6 Years

Max age

11 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Students in grades 1 to 4 from participating primary schools. * Non-myopic children with insufficient hyperopic reserve, defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D and below the following age-specific upper limits: +1.72 D at age 6 years; +1.48 D at age 7 years; +1.19 D at age 8 years; +1.11 D at age 9 years; +0.92 D at age 10 years; and +0.83 D at age 11 years. * Written informed consent provided by a parent or legal guardian, with 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.

Primary outcome measure(s)

Change in axial length — Baseline to 12 months
Defined as the difference in axial length between the 12-month follow-up visit and baseline.

Trial sites (1)

Facility	City	Region	Status
Shanghai Eye Disease Prevention and Treatment Center	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07746804 on ClinicalTrials.gov ↗ ← All trials in China