Clinical Study on Brain Visual Perception Training for Prevention and Control of Myopia in Children With Premyopia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 主要终点
- changes in axial length after 1 year
研究概览
简要总结
The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training.
The main questions it aims to answer are:
Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children
Participants will:
The training group will receive 20 minutes of brain visual perception training once a day for a period of one year.
Follow up check ups at the hospital every 3 months. Keep a diary of the values of axial length and refractive diopter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-10 years with premyopia, defined as a cycloplegic spherical equivalent refraction (SER) of the more myopic eye in the range of -0.50 to 0.75 (inclusive) diopters (D) and having at least 1parent with an SER in either eye of -3.00D or less.
排除标准
- •Children have astigmatism of 1.50D or more, anisometropia of 1.50 D or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions.
结局指标
主要结局
changes in axial length after 1 year
时间窗: 1 year after the baseline
the difference in the changes of axial length between the intervention group and the control group
次要结局
- changes in cycloplegic spherical equivalent after 1year(1 year after the baseline)