Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Eye--Refractive Errors
- 发起方
- Sun Yat-sen University
- 入组人数
- 1680
- 主要终点
- Incidence of SER development of at least -0.5 dioptres (D)
- 最后更新
- 6年前
概览
简要总结
In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.
详细描述
We propose to enroll Grade 3 children from primary schools in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.
研究者
Haotian Lin
Clinical Professor
Sun Yat-sen University
入排标准
入选标准
- •Children at Grade 3 (aged 8-9)
- •Has the record of eye refraction examined in the past year
- •Written informed consents provided
排除标准
- •Definitive diagnosis of other ocular abnormalities except for refractive error
- •Previous eye surgery
- •Unwilling to participate in this trial
结局指标
主要结局
Incidence of SER development of at least -0.5 dioptres (D)
时间窗: Up to 1 year
SER: sphere + ½ 360 cylinder; SER development of at least -0.5 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 1 year
次要结局
- Changes in SER \and AL(Up to 1 year)
- Changes in proportion of children using spectacles(Up to 1 year)
- Changes in child's average screen time per day(Up to 1 year)
- Changes in proportion of children using atropine(Up to 1 year)
- Changes in child's average outdoor activity time per day(Up to 1 year)
- Changes in proportion of children using orthokeratology lenses(Up to 1 year)