NCT06727019已完成不适用
Daily Low-level Red Light and 0.01% Low-dose Atropine for Myopia Prevention
Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2023年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Incidence of myopia
研究概览
简要总结
To compare the preventive effects of daily low-level red-light and 0.01% low-dose atropine eye drops on myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged at least 7 years old.
- •The spherical equivalent error (SER) after pupil dilation was between -0.5 D and +0.75D.
- •Had a record of cycloplegia SER at least 6 months before this study, and SER changed -0.5D compared with the last measurement or had a family history of high myopia.
- •Corneal astigmatism ≤ 1.25D.
- •Interocular refraction discrepancy ≤ 1.5D.
- •No allergy history of cycloplegia drugs.
- •Willingness to participate in the study and signed informed consent.
排除标准
- •Intraocular pressure was below 10 mm Hg or higher than 22 mm Hg.
- •Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders.
- •Children currently using other myopia interventions other than LDA or LLRL.
- •Children with systemic and immune disorders, such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, and diabetes
- •Individuals with conditions like Tourette's syndrome or epilepsy.
研究组 & 干预措施
red-light
Experimental
In the low-level red-light (LLRL) group, the children used LLRL irradiation twice a day for 3-minute sessions, ensuring a gap of over 4 h between each use
干预措施: low-level red-light (Device)
atropine
Experimental
participants in the atropine group used 0.01% low-dose atropine eye drops once each night
干预措施: Atropine (0.01%) (Drug)
结局指标
主要结局
Incidence of myopia
时间窗: 12 months
12-month incidence of myopia
次要结局
未报告次要终点
研究者
cao kai
Dr
Beijing Tongren Hospital
研究点 (1)
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