A Real-world Study to Evaluate the Efficacy of 650nm Low-intensity Single-wavelength Red Light in the Prevention and Control of Myopia in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Change in spherical equivalent error
研究概览
简要总结
To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.
详细描述
This multicenter real world study will be conducted in at least 100 hospitals: Beijing Tongren Hospital will be the initiator of the study, other hospitals such as the Capital Institute of Pediatrics will serve as sub-centers. The whole study will last for three years.The investigators will perform data analysis at 6 months follow-up, one-year follow-up, and two-year follow-up. Participants who used 650 nm low-level red-light would be recruited. This kind of intervention will be integrated into a headworn device. This device could be used for treatment of myopia or amblyopia, and is safe for the eyes and has been verified by the Chinese market supervision and administration department.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Children aged 7 to 18 years
- •The cycloplegic spherical equivalent error (SER) is +0.5D or less in both eyes
- •Astigmatism of 2.5 D or less (≤2.5D)
- •Willing to participate in the study and sign the informed consent form
排除标准
- •Including but not limited to the following eye diseases: strabismus, amblyopia, ocular tumors, glaucoma/macular disease and other fundus diseases (including heredity), keratitis, eye trauma, uveitis
- •Including but not limited to the following systemic diseases: epilepsy, tumor, heart disease, asthma, systemic immune diseases, infectious diseases
- •Mental diseases
- •Similar interventions have been used in the past year
- •Allergic to cycloplegic agents or to red light
- •The 650nm red light intervention was not suitable for the condition evaluated by the researchers
- •are currently using atropine or similar drugs, or have stopped using them for less than 1 month
结局指标
主要结局
Change in spherical equivalent error
时间窗: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Children's pupil were dilated using Mydrin-P eye drops, and then the refractive error was measured using an autorefractor. the two measurements (axial length and spherical equivalent error) will be aggregated to arrive at one reported value through the following way: axial enlongation will be defined as progress in myopia, decrease in spherical equivalent error will be defined as progress in myopia too.
Change in axial length
时间窗: Baseline, six-month follow-up, one-year follow-up, two-year follow-up
Use an optical biometer to measure the axial length
次要结局
- Change in Choroid thickness to measure(Baseline, six-month follow-up, one-year follow-up, two-year follow-up)
- Change in flat keratometry(Baseline, six-month follow-up, one-year follow-up, two-year follow-up)
- Change in length thickness(Baseline, six-month follow-up, one-year follow-up, two-year follow-up)
- Change in steep keratometry(Baseline, six-month follow-up, one-year follow-up, two-year follow-up)
- Change in anterior chamber depth(Baseline, six-month follow-up, one-year follow-up, two-year follow-up)
- Change in central corneal thickness(Baseline, six-month follow-up, one-year follow-up, two-year follow-up)
研究者
Ying Jie, MD
Prof
Beijing Tongren Hospital