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
干预措施
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.
研究组 & 干预措施
Intervention
Experimental
Red light irradiation was conducted at school from Monday to Friday and at home everyday in summer and winter holiday twice a day for 3 minutes per time, with an interval of 4 hours
干预措施: LLLT（Low Level Laser Therapy） (Device)
Control
No Intervention
No intervention
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)
Loading locations...
相似试验
Unknown
不适用
Red Light Intervention on Myopic ProgressionMyopiaNCT05203432Shanghai Eye Disease Prevention and Treatment Center104
Unknown
不适用
Efficacy of Repeated Low-Level Red-Light Therapy in Myopia ControlEye DiseasesRefractive ErrorsMyopiaNCT04073238Zhongshan Ophthalmic Center, Sun Yat-sen University264
招募中
不适用
Efficacy of Repeated Low-level Red-light Therapy in Myopia ControlMyopiaNCT05606237University of California, San Francisco90
招募中
不适用
Slow Myopia Progression With Different Irradiance LightMyopia, ProgressiveNCT05881655Beijing Airdoc Technology Co., Ltd.75
已完成
不适用
The Effectiveness and Safety of Low-intensity Single-wavelength Red Light in Controlling High Myopia in Children and Adolescents：A Randomized, Controlled, Multicenter Clinical TrialClinical Diagnosis Confirming That Myopia Has Occurred in at Least One EyeAge 3 to 16 Years (Inclusive), Male or FemaleThe Guardian Voluntarily Signed the Subject's Informed Consent FormNCT05184621Shanghai Eye Disease Prevention and Treatment Center192