Real-world Registry Study of Red Light Treatment on Myopia Control: a Focus on Non-responders to Conventional Treatments
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,500
- 主要终点
- The proportion of fully controlled
研究概览
简要总结
This real-world observational registry study aims to assess the effectiveness of Repeated Low-Level Red Light (RLRL) therapy in controlling myopia progression among children aged 8 to 16 who have not responded to conventional treatments like Orthokeratology and atropine eyedrops. The primary focus is to determine if RLRL therapy can limit axial length (AL) elongation to less than 0.1mm per year and spherical equivalent refraction (SER) progression to less than 0.25 diopter per year, while also evaluating safety and visual outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 8 to 16 years at the time of data collection, aligning with the approved usage guidelines of the RLRL device.
- •Diagnosed with myopia and have been under conventional myopia treatments (include Orthokeratology, defocus incorporated multiple segments spectacles or equivalent, and 0.01% atropine or 0.05% atropine eyedrops) for at least six months. Eligible patient data must demonstrate insufficient control of myopia progression, defined as an axial elongation of 0.3 mm or more, or SER progression of 0.5 diopter or greater per year.
- •Best corrected visual acuity (BCVA): 20/20 or greater.
- •Data from patients who have utilized or are utilizing red light therapy as part of their myopia management strategy.
排除标准
- •Ophthalmic diseases other than refractive errors, including but not limited to strabismus and binocular vision abnormalities in either eye.
- •Presence of systemic diseases (e.g., endocrine, cardiac diseases) and developmental abnormalities.
- •Concurrent use of atropine eye drops and RLRL therapy.
结局指标
主要结局
The proportion of fully controlled
时间窗: 12 months for each participate
The proportion of the people with AL elongation of less than 0.1mm per year or SER progression of less than 0.25 diopter per year after RLRL therapy for 12 months.
次要结局
- Optical coherence tomography (OCT) scan changes (eg. choroidal thickness changes on OCT scans.)(12 months for each participate)
- BCVA changes(12 months for each participate)