A Prospective, Multi-center Study of the Effect of Orthokeratology on Myopia Progression in Chinese Children
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 8
- 主要终点
- AUROC of the prediction algorithm for identifying fast progressing myopes
研究概览
简要总结
This is a prospective study to validate an algorithm for predicting the effect of orthokeratology on myopia progression in children from 8 hospitals in China.
详细描述
Orthokeratology (ortho-K) is thought to be an effective way to control the progression of Myopia in children, but its effectiveness may vary among different individuals. The investigators therefore conducted a prospective, multi-center study to use an algorithm to predict the progression of myopia among Chinese children wearing Orthokeratology lenses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-6.0D≤SER≤-0.5D
- •Astigmatism≤2.0D
排除标准
- •Contraindications of wearing Ortho-K.
- •Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
- •Currently involved in other clinical studies.
结局指标
主要结局
AUROC of the prediction algorithm for identifying fast progressing myopes
时间窗: 1 year
Age-specific axial length (AL) changes previously described by Wang et al.(IOVS, 52 (11), 7949-53, 2011) are used as cut-off values to determine whether a child is a fast progressor or not. A child whose AL change falls on or above the cut-off value is considered to be a fast progressor.
次要结局
- Performance of an algorithm for predicting AL(1 year)
- Performance of an algorithm for predicting spherical equivalent refractive error(1 year)
- Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes(1 year)