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

Официальное название

A Randomized Controlled Trial of a School-based Wearable Device-Supported Outdoor Activity Program for Myopia Prevention in Children With Adequate Hyperopic Reserve

Обзор

This is a prospective, school-based randomized controlled trial designed to evaluate a wearable device-supported outdoor activity program for myopia prevention in primary school students with adequate hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either a wearable device-supported outdoor activity program plus routine school-based eye health education or routine school-based eye health education alone. 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 adequate hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the age-specific criteria for adequate hyperopic reserve based on cycloplegic spherical equivalent refraction in the worse eye and whose parents or legal guardians provide written informed consent.

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 routine school-based eye health education and wearable device-supported monitoring and reminders for outdoor activity. The control group will receive routine school-based eye health education and maintain usual daily activities without wearable device-supported outdoor activity monitoring or reminders.

Baseline and follow-up assessments will include ophthalmic examinations according to the study protocol. An interim follow-up assessment will also 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, achievement of outdoor activity targets, adherence to wearable device use, and safety outcomes and adverse events.

Вмешательства

• Поведенческое Wearable Device-Supported Myopia Prevention Program
  The wearable device-supported program will use smart wearable wristbands to monitor outdoor activity time and provide reminders. Students in the intervention group will be encouraged to increase outdoor activity, with targets of at least 1 hour per day on school days and at least 2 hours per day on weekends. Data recorded by the wearable device will be used to quantify daily outdoor activity and assess adherence to the intervention.
• Поведенческое Eye Health Education
  Routine school-based eye health education will include general guidance on healthy visual behaviors, including reducing prolonged near work, maintaining appropriate reading posture and lighting conditions, performing standard eye exercises, and undergoing 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 Wearable Device Use [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 schools.
• Non-myopic children with adequate hyperopic reserve at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye within the following age-specific reference ranges: +1.72 D to +2.45 D at age 6 years; +1.48 D to +2.00 D at age 7 years; +1.19 D to +1.79 D at age 8 years; +1.11 D to +1.38 D at age 9 years; +0.92 D to +1.16 D at age 10 years; and +0.83 D to +1.07 D at age 11 years.
• Written informed consent provided by a parent or legal guardian, with assent obtained from the child when appropriate.

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.
• 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: NCT07746752 · KY2026-001-RE-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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