Effects of Low-Level Red Light and Distant-Image Screen for Myopia Control in Children: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Changes in axial length
研究概览
简要总结
This study aims to assess the efficacy and safety of daily exposure to 650-nm low-level red light (RL) and distant-image therapy (DIT) for myopia treatment.
详细描述
This was a randomized clinical trial. Children aged 8 to 10 years with a spherical equivalent error (SER) ranging from -1 to -1.5 diopters (D) were enrolled, and were randomly allocated to the following treatment group: RL, DIT, RL plus DIT, and control in a 1:1:1:1 ratio. The primary outcomes were one-year change in SER and axial length.
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
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8 and 10 years old.
- •The spherical equivalent error after pupil dilation was between -1.0 D and -1.5D.
- •Corneal astigmatism ≤ 1.25D.
- •Interocular refraction discrepancy ≤ 1.5D.
- •Near-distance exophoria < 10 prism diopters (△) and far-distance exophoria < 6 prism diopters (△).
- •Willingness to participate in the study and signed informed consent.
排除标准
- •Intraocular pressure was below 10 mmHg or higher than 22 mm Hg.
- •Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders.
- •Children currently using atropine or orthokeratology for myopia control.
- •Patients with systemic and immune disorders such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, diabetes, etc.
- •Individuals with conditions like Tourette's syndrome or epilepsy.
结局指标
主要结局
Changes in axial length
时间窗: one year
Axial length was measured using an optical biometer (Colombo IOL, Moptim)
Changes in spherical equivalent error
时间窗: one year
Spherical equivalent error was calculated from the dioptric powers of the sphere and half of the cylinder.The children's pupils were dilated using tropicamide eyedrops, then SER was subsequently measured using an auto refractor (ARK-510A, Nidek Co Ltd)
次要结局
未报告次要终点
研究者
cao kai
Dr
Beijing Tongren Hospital