NCT06926556已完成不适用
Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 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 different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 -0.50D~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
- •Within 30 days, 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
- •Diagnosed constant strabismus;
- •Diagnosed pathological myopia;
- •Other congenital eye diseases;
- •Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
研究组 & 干预措施
H.M.E.C，High Precision Micro Encircle
Experimental
干预措施: Defocus microlenses (Device)
H. A. L. T, highly aspheric lenslet technology
Active Comparator
结局指标
主要结局
Subjective refraction equivalent spherical
时间窗: 2 years
次要结局
- Axial length(2 years)
研究者
研究点 (1)
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