NCT07284147Enrolling By Invitation不适用
Clinical Study on the Control Effect of 3D Designed Defocus Lenses on Myopia in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Subjective refraction equivalent spherical
研究概览
简要总结
This study aims to evaluate the effectiveness of lenses with 3D Designed Defocus in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 6-14 years old; After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.40D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is ≤ 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0; Within 3 months, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used; The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.
排除标准
- 未提供
结局指标
主要结局
Subjective refraction equivalent spherical
时间窗: 12 months
Subjective refraction equivalent spherical
次要结局
- Axial length(12 months)
- Choroidal thickness(12 months)
研究者
研究点 (1)
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