NCT06221592Enrolling By Invitation不适用
Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens 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
- Single (Participant)
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 0.00D~-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.
结局指标
主要结局
Axial length
时间窗: 2 years
The change of axial length.
次要结局
- Subjective refraction equivalent spherical(2 years)
研究者
研究点 (1)
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