Impact of Feedback Based on the Myopia Prediction System on High Myopia Risk and Consultation Behavior in School-aged Children: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Proportion of Individuals Predicted to Develop High Myopia at Age 18 by the Myopia Prediction System
研究概览
简要总结
The global rise in myopia, particularly among children and adolescents in China, underscores the inadequacy of current prevention strategies, indicating that conventional screening and education alone are insufficient to curb the prevalence. Integrating personalized myopia prediction into routine care may enhance risk awareness, promote proactive prevention, and improve adherence to medical advice, ultimately reducing the future burden of high myopia.
A myopia prediction system based on artificial intelligence was previously developed, accurately predicting future high myopia risk using efficient, robust, and easily accessible predictive factors, including age, spherical equivalent, and the annual progression of spherical equivalent. This study aims to conduct a prospective, one-year, cluster randomized controlled clinical trial to investigate the effectiveness of this prediction system in preventing and controlling myopia in school-aged children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant and their guardian voluntarily signed the informed consent form
- •Has the record of eye refraction examination in the past year
- •Aged 9 to 11 years, regardless of gender
排除标准
- •High myopia(spherical equivalent ≤ -6.00 D)
- •Ocular diseases other than myopia (e.g., strabismus, amblyopia, congenital cataract, juvenile glaucoma, retinal diseases).
- •Systemic diseases that may affect vision or visual development (e.g., diabetes or other endocrine disorders, cardiovascular or respiratory diseases, Down syndrome)
结局指标
主要结局
Proportion of Individuals Predicted to Develop High Myopia at Age 18 by the Myopia Prediction System
时间窗: 1 year
At the end of the one-year study, the Myopia Prediction System will be used to predict whether students will develop high myopia at age 18 in both the intervention and control groups. The Proportion of Individuals Predicted to Develop High Myopia at Age 18 by the Myopia Prediction System is calculated as the total number of students in each group predicted to develop high myopia by age 18, divided by the total number of students in the respective group.
Cumulative Clinical Visit Rate for Myopia Prevention and Control
时间窗: Within 3 months after each intervention
The Cumulative Clinical Visit Rate Proportion of Clinical Visits for Myopia Prevention and Control is the proportion of students in the intervention or control group who visited a hospital or clinic for myopia-related care (e.g., refractive exams and treatment) at least once within three months of either intervention. It is calculated as the number of students in each group who attended a clinical visit within three months of at least one intervention, divided by the total number of students in the respective group.
次要结局
- Screen Time(1 year)
- Outdoor Activity Time(1 year)
- Myopia Incidence Rate(1 year)
- Changes in Spherical Equivalent(1 year)
研究者
Haotian Lin
Prof.
Zhongshan Ophthalmic Center, Sun Yat-sen University