Clinical Study of Low Lever Red Light Therapy With 650nm to Control Myopia Progression in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Changes in axial length (mm）
研究概览
简要总结
Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.
详细描述
LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
- •Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D);
- •Best corrected vision in one eye under glasses correction: 0.1 log MAR;
- •No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
- •No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);
排除标准
- •Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
- •Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
- •Subject participated in other clinical trials within 4 weeks before the enrollment;
- •The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -
结局指标
主要结局
Changes in axial length (mm）
时间窗: at 1-month Follow-up
Changes of axial length at 1-Month follow-up from baseline with IOLmaster 500 Axial length measurement at baseline and at follow-up with IOLmaster(Carl Zeiss). Five measurements were taken and averaged. The changes will be calculated by the formula as below: Change in axial length ( mm ) = Axial length value at follow-up baseline
次要结局
- Changes in cycloplegic autorefraction (diopters, D)(at 1-month Follow-up and at baseline)
- Changes of choroidal thickness under macular foveal (um)(at 1-month Follow-up and at baseline)
- Change in retina fovea perfusion density (RFPD, %)(at 1-month Follow-up and at baseline)
- Changes of cornea power(at 1-month Follow-up and at baseline)