Is Non-cycloplegic Photorefraction Applicable for Screening Refractive Risk Factors of Amblyopia?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- refraction
研究概览
简要总结
Purpose: : This study was performed to compare the accuracy of non-cycloplegic photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors and determine some corresponding beneficial cut points.
Method: In this diagnostic accuracy study, right eyes of 185 children (1 to 14 years) underwent first non-cycloplegic photorefraction (with PlusOptix SO4 photoscreener) and then cycloplegic refraction from October 2009 to August 2010. Based on the cycloplegic refraction results, hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines. The difference in detection of refractive amblyopia risk factors between the two methods was the main outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 1 year old /with consent
排除标准
- •mental retardation
- •impaired fixation
- •strabismus
- •ptosis and any other organic ophthalmic disorder interfering with refraction
结局指标
主要结局
refraction
时间窗: 10 months
cycloplegic auto refraction \& Non-cycloplegic photorefraction
次要结局
- hyperopia (≥+3.5D), myopia (≥-3D), astigmatism (≥1.5D), and anisometropia (≥1.5D) were set as criteria based on AAPOS guidelines.(10 months)