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

Официальное название

A Randomized Controlled Trial of School-based Auricular Acupressure for Myopia Prevention in Non-myopic Children With Insufficient Hyperopic Reserve

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 time
• Поведенческое 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.

Первичные конечные точки

• Change in axial length [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (4)

• Change in cycloplegic spherical equivalent refraction [Срок оценки: Baseline to 12 months]
• Incidence of myopia during follow-up [Срок оценки: During the 12-month follow-up period]
• Adherence to auricular acupressure [Срок оценки: During the 12-month follow-up period]
• Safety Outcomes and Adverse Events [Срок оценки: During the 12-month follow-up period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Shanghai Eye Disease Prevention and Treatment Center — Шанхай

Идентификаторы

NCT: NCT07746804 · KY2026-001-RE-012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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