School-based Myopia Control Trial for Children With Premyopia or Myopia

Shanghai Eye Disease Prevention and Treatment Center358 enrolled

Overview

This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Enrolled students in grades 1 to 4 will be randomly assigned to either defocus spectacle lenses combined with auricular acupressure or defocus spectacle lenses alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes over 12 months.

This prospective, school-based randomized controlled trial will be conducted among primary school students with premyopia or myopia. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the study criteria for premyopia or myopia based on cycloplegic spherical equivalent refraction and whose parents or legal guardians provide written informed consent. Premyopia is defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D. Myopia is defined as cycloplegic spherical equivalent refraction in the worse eye less than or equal to -0.50 D. 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 defocus spectacle lenses combined with auricular acupressure according to the study protocol. The control group will receive defocus spectacle lenses alone according to the study protocol. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. Auricular acupressure will be delivered by trained medical personnel using auricular acupressure patches applied to selected auricular acupoints according to the standardized study protocol. 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, adherence to the assigned intervention, and safety outcomes and adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Interventions

Defocus Spectacle LensesDEVICE

Defocus spectacle lenses will be prescribed and fitted for eligible participants according to standardized procedures. The lenses are designed to provide refractive correction while introducing peripheral myopic defocus for myopia control. Participants with premyopia will be instructed to wear the spectacles for at least 8 hours per day, while participants with myopia will be instructed to wear them for at least 12 hours per day. Lens fitting, adaptation, follow-up, and any lens or frame adjustments will be monitored and documented during the study period. If adjustments are required due to discomfort, prescription change, poor fit, or lens/frame damage, they will be managed according to standardized procedures whenever feasible. Participants will remain in their originally assigned group for the primary intention-to-treat analysis, and lens-wear adherence and major lens adjustments may be considered in per-protocol or sensitivity analyses.

Auricular AcupressureOTHER

Auricular acupressure will be performed using auricular acupressure patches applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once per week 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. Adherence to auricular acupressure will be assessed based on attendance at scheduled sessions, patch retention, and completion of participant pressing instructions recorded by study personnel or school health teachers. 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.

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in axial length from baseline to 12 months

Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.

Time frame: Baseline to 12 months

Secondary Outcomes

Change in cycloplegic spherical equivalent refraction from baseline to 12 months

Change in cycloplegic spherical equivalent refraction is defined as the difference between the 12-month value and the baseline value.

Time frame: Baseline to 12 months

Adherence to the assigned intervention

Defined as adherence to the assigned intervention during the study period, including attendance at scheduled auricular acupressure sessions, patch retention, completion of participant pressing instructions, and spectacle lens wear as applicable.

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 or defocus spectacle lens wear, including local skin irritation, allergy, pain, itching, redness, swelling, ear discomfort, visual discomfort, dizziness, or other spectacle-related discomfort.