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

Официальное название

A Randomized Controlled Trial of Auricular Acupressure Combined With Defocus Spectacle Lenses for Myopia Control in Children With Premyopia or Myopia

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Defocus Spectacle Lenses
  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 adjustm
• Другое Auricular Acupressure
  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

Первичные конечные точки

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

Вторичные конечные точки (3)

• Change in cycloplegic spherical equivalent refraction from baseline to 12 months [Срок оценки: Baseline to 12 months]
• Adherence to the assigned intervention [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.
• 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.

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: Нет

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: NCT07746778 · KY2026-001-RE-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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