NCT05203432Unknown不适用
The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Changes of axial length
研究概览
简要总结
To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at enrolment: 6-12 years;
- •At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;
- •Anisometropia of 1.5 D or less;
- •The BCVA of distant vision is at least 0.8;
- •Myopia progressed more than 0.5D in the past year;
- •Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
- •Written informed consent of guardian and child.
排除标准
- •Strabismus, amblyopia or other ocular abnormalities;
- •Other systemic abnormalities;
- •Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;
- •Atropine allergy;
- •Other situations that not suitable for participating in the trial as judged by the researcher.
研究组 & 干预措施
Red Light Intervention
Experimental
Repeated Low-Level Red-Light Therapy
干预措施: Red Light Intervention (Device)
Low concentration atropine
Active Comparator
0.01% atropine
干预措施: Atropine (Drug)
结局指标
主要结局
Changes of axial length
时间窗: at least 1 year
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster
次要结局
- Change of choroidal thickness(at least 1 year)
- Change of spherical equivalent(at least 1 year)
- Change of uncorrected visual acuity(at least 1 year)
研究者
研究点 (1)
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