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

Shanghai Eye Disease Prevention and Treatment Center130 enrolled

Overview

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.

This prospective, school-based randomized controlled trial will be conducted among non-myopic children with insufficient hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the eligibility criteria for insufficient hyperopic reserve and whose parents or legal guardians provide written informed consent. Insufficient hyperopic reserve is defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D but lower than the age-specific reference value for hyperopic reserve. Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive auricular acupressure administered according to the study protocol in addition to standard school-based eye health education. The control group will receive standard school-based eye health education only and will not receive auricular acupressure or other additional study-related myopia prevention intervention. Comprehensive ophthalmic examinations will be conducted at baseline and 12 months according to the study protocol. An interim follow-up visit will be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, the incidence of myopia during follow-up, adherence to auricular acupressure, and safety outcomes and adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

Auricular AcupressureOTHER

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 EducationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in axial length

Defined as the difference in axial length between the 12-month follow-up visit and baseline.

Time frame: Baseline to 12 months

Secondary Outcomes

Change in cycloplegic spherical equivalent refraction

Defined as the difference in cycloplegic spherical equivalent refraction between the 12-month follow-up visit and baseline.

Time frame: Baseline to 12 months

Incidence of myopia during follow-up

Defined as the proportion of participants who develop myopia during the 12-month follow-up period. Myopia is defined as uncorrected visual acuity less than 5.0 in either eye and non-cycloplegic spherical equivalent refraction less than -0.50 D in either eye.

Time frame: During the 12-month follow-up period

Adherence to auricular acupressure

Defined as adherence to scheduled auricular acupressure sessions during the study period.

Time frame: During the 12-month follow-up period

Safety Outcomes and Adverse Events

Defined as the occurrence of any adverse events related to auricular acupressure, including local skin irritation, allergy, pain, itching, redness, swelling, or other ear discomfort.

Time frame: During the 12-month follow-up period

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts