NCT04825769已完成不适用
A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- One-year cumulative incidence of myopia (%) in the intervention group and the control group.
研究概览
简要总结
To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Students of grade 1-4 in the participating schools;
- •Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） >-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D <cycloplegic SE≤0.50D;
- •Students whose mother and/or father are in myopia status (SE < -3.0D for either of eyes);
- •Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.
排除标准
- •Students whose parents do not sign informed consent;
- •Students who have strabismus and/or other binocular vision abnormality;
- •Students who have other eye diseases and/or systematic diseases;
- •Students who have DC <=-1.5D;
- •Students whose difference of SE between the two eyes >=1.5D;
- •Students who meet the standards with which investigators and study physicians think it is not appropriate to enroll.
结局指标
主要结局
One-year cumulative incidence of myopia (%) in the intervention group and the control group.
时间窗: 1 year
Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D
次要结局
- The progress of spherical equivalent(SE,D) of children in intervention group and control group.(1 year)
- The progress of axial length of children in intervention group and control group.(1 year)
- The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.(1 year)
- The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.(1 year)
研究者
研究点 (1)
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