Random、Control and Open Study of Real Word Study on Myopia Control With Repeated Red Light Therapy for Ages of 3~6 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean changes of axial length vaules by millimeter at follow-up from baseline.
研究概览
简要总结
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported.
详细描述
Repeated Red Light Therapy had been used as an amblyopia therapy for children as well as the myopia control in primary schools. However, ultra low lever of red light therapy with irradiance of 0.37mW and 0.60mW effectiveness and safety for 3~ 6 year-old myopia treatment or slow myopia progression are seldom reported. Here we design this control and random prospective study to find the two types light with different irridance to two ages (3~4 years old and 5~6 years old) respectively. Wether the dose and effectiveness exit or not for 3~6- year- old myopia control.
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
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3~6 years old;
- •Myopia Spherical Equivalence Refraction <=-0.50D;
- •Written Informed Consent;
排除标准
- •Cannot approval with written informed consent;
- •Photophobia or allergy to red light;
- •With other severe conditions the principle investigators refused to enroll this study
研究组 & 干预措施
repeated red light therapy for 3~4 year-old myopia
0.37mW lighting with wavelength of 650nm for the age of 3~4 years old(including both 3 and 4 years)myopia.
干预措施: repeated ultra low lever red light (Device)
repeated red light therapy for 5~6 year-old myopia
0.60mW lighting with wavelength of 650nm for the age of 5~6 years old(including both 5 and 6 years)myopia.
干预措施: repeated ultra low lever red light (Device)
结局指标
主要结局
Mean changes of axial length vaules by millimeter at follow-up from baseline.
时间窗: at 3-month and at 6-month
Ocular axial length measured by IOLmaster500 or Lenstar will be measured and recorded at follow-ups and at baseline. The changes values of axial length of both groups will be compared as the main outcome to compare the effectiveness of repeated red light thearpy.
次要结局
- Numbers of children without myopic refraction changes by spherical equivalence values from refraction at follow-up from baseline(D)(at 3-month and at 6-month)
- Number of Participants with unsafety issues during the study(at 6-month)