Effect of Orthokeratology on Myopia Progression in Chinese Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Axial length
研究概览
简要总结
Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages Eligible for Study: 7 Years to 14 Years
- •Genders Eligible for Study: Both
- •Visual acuity 20/20 or better in each eye
- •Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes
- •No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development
排除标准
- •Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on)
- •Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing
研究组 & 干预措施
Orthokeratology in the first year
The participants would wear orthokeratology in the first year and then switch to spectacle in the second year
干预措施: Orthokeratology (Device)
Orthokeratology in the first year
The participants would wear orthokeratology in the first year and then switch to spectacle in the second year
干预措施: Spectacle (Device)
Spectacle in the first year
The participants would wear spectacle in the first year and then changed to orthokeratology in the second year
干预措施: Orthokeratology (Device)
Spectacle in the first year
The participants would wear spectacle in the first year and then changed to orthokeratology in the second year
干预措施: Spectacle (Device)
结局指标
主要结局
Axial length
时间窗: Change from baseline at 2 years
Refraction
时间窗: Change from baseline at 2 years
次要结局
- Tear film break up time(BUT)(Change from baseline at 2 years)
- Self evaluation of comfortableness(Change from baseline at 1 year)
- Corneal endothelial cell density(Change from baseline at 2 years)
- Self evaluation of comfortness(Change from baseline at 2 years)
研究者
Shi-Ming Li
Dr.
Beijing Tongren Hospital