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

Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Study ID
NCT07746804
Status
Recruiting
Apply to this trial

Conditions

  • Hyperopia
  • Myopia
  • Refractive Errors

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • Auricular Acupressure — OTHER
    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 — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Jun 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    Participants in the intervention group will receive auricular acupressure for myopia prevention during the 12-month study period. The intervention will be delivered by trained medical personnel according to a standardized protocol.
  • Active Comparator: Control Group
    Participants in the control group will receive standard school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive auricular acupressure or other additional study-related myopia prevention intervention.

Primary Outcome Measure

Change in axial length [ Time Frame: Baseline to 12 months ]

Central Contacts

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