The Children's WEAR (Wearability and Evaluation of Adjustable Refraction) Trial(Phase 1&2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Visual acuity with and without study refractive correction
研究概览
简要总结
Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: (September 2012 - August 2013)
详细描述
Phase I: Focus groups on different designs of adjustable glasses and standard glasses (August-September 2012) Phase II: Two-month randomized trial comparing four groups: self-refraction with adjustable glasses, receiving custom standard glasses; subjective refraction by an expert refractionist after cycloplegic automated refraction and receiving custom standard glasses; subjective refraction by a rural refractionist after cycloplegic automated refraction, receiving custom standard glasses; and subjective refraction by an expert refractionist after cycloplegic automated refraction receiving ready made glasses (September 2012 - August 2013)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •phase1: - aged 12-17 years
- •with <= -1.00D of myopic refractive error in each eye phase2: - 12-15 years old children from two locations in Guangdong Province
- •with uncorrected vision </= 6/12 in at least one eye thought to be due to refractive error (that is, correctable to at least 6/7.5 with cycloplegic subjective refraction by an optometrist)
排除标准
- •those corrected VA can not up to 6/7.5 with cycloplegic subjective refraction by an optometrist
- •those with significant strabismus or vision abnormality (keratopathy, cataract, vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to be excluded.
- •Children developing acquired vision problems other than myopia
结局指标
主要结局
Visual acuity with and without study refractive correction
时间窗: 2 months
次要结局
- Value attached to the glasses and satisfaction to the glasses(2 months)
- frequency of glasses-wear and the reason why the frequency is low(2 months)
- Self-reported and Supplemental visual functioning(2 months)
- Accuracy of spectacles given to children(2 months)
研究者
Congdon Nathan
MD,MPH
Sun Yat-sen University