NCT05478356Unknown不适用
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control
Evidence Based Cataract Study Group2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Progression of myopia
研究概览
简要总结
Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia progression.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Best corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more.
排除标准
- •Children with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D.
- •History of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity.
- •History of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.
研究组 & 干预措施
orthokeratology group
Experimental
干预措施: orthokeratology (Device)
low-dose atropine group
Active Comparator
干预措施: low-dose atropine eye drops (Drug)
结局指标
主要结局
Progression of myopia
时间窗: 1 year
The change of myopia (Ds)
Progression of axial length
时间窗: 1 year
The change of axial length (mm)
次要结局
未报告次要终点
研究者
Peng ZHOU
Doctor
Evidence Based Cataract Study Group
研究点 (2)
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