NCT06821074招募中不适用
Comparative Study of Visual Function Training With Defocus-Enhanced Spectacles vs. Single Vision Spectacles on Myopia Control in Children
Beijing Visionly Plus Eye Hospital2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年2月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in spherical equivalent 12 months after the commencement of training.
研究概览
简要总结
The purpose of this study is to compare the effectiveness of vision function training using defocus-enhanced spectacles (DIMS) versus single vision spectacles combined with vision function training in controlling myopia progression in children aged 6-18 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6-18 years.
- •Diagnosed myopia with SER between -0.50D and -4.00D.
- •Astigmatism ≤ 2.50DC.
- •Anisometropia < 1.25D.
排除标准
- •Suspected genetic syndromes (e.g., Stickler, Marfan).
- •Other eye diseases (e.g., glaucoma, cataracts, retinal abnormalities, strabismus).
- •Myopia progression <0.50D SER in the last year.
研究组 & 干预措施
Defocus-enhanced spectacles
Experimental
Vision function training while wearing defocus-enhanced spectacles
Single vision spectacles
Placebo Comparator
Vision function training while wearing single vision spectacles
干预措施: Single vision spectacles (Device)
结局指标
主要结局
Change in spherical equivalent 12 months after the commencement of training.
时间窗: Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.
Change in spherical equivalent 12 months after the commencement of training.
次要结局
- Change in axial length 12 months after the commencement of training.(Regular sessions commenced from the day of the initial training and continued until 12 months after the first visual training session.)
研究者
研究点 (2)
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