Randomized Controlled Study on Subjective Refraction by Software Eye Test Technology Versus Retinoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Astigmatism axial
研究概览
简要总结
Software refraction in the mobilerone for myopia and astigmatism is a novel medical device for myopia adults and elder children with or without astigmatism. And the investigators would like to test its accuracy and efficacy as well as safety.
详细描述
It's a software installed in a mobilerone with subjective guide on screen for testing myopic refractive error with or without astigmatism for adults or elder children. The investigators would like to compare its refraction results with retinoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 46 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• subject with ametropia on each eye ≤-12.00D
- •subject with best corrected visual acuity ≥ 20/25, no amblyopia
- •subject with normal transparency of eyes
- •subject with a healthy fundus that does not reveal major abnormalities that may affect vision due to the fluctuate situations
- •subject able to cooperate with the screen and the operator
- •subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
- •non-diabetic subject
- •non nystagmus subject
- •non-strabismus subject
- •subject who has not had eye surgery less than 1 year old
排除标准
- •• subject with a topography showing an anomaly (keratoconus type or other)
- •subject with hyperopia or presbyopia
- •subject with mild myopia ≥ -1.00D
- •subject who cannot speak with the operator including those staff of local optometrists or ophthalmologists
研究组 & 干预措施
Software Refraction
Refraction is done by software with subjective refraction through a mobilerone.
干预措施: Software refraction with Eye Test Technology in a mobilerone (Device)
Refraction by retinoscopy
Refraction is done objectively by retinoscopy.
干预措施: Retinoscopy (Device)
结局指标
主要结局
Astigmatism axial
时间窗: 1-day and within 2 weeks
Cylinder axis of astigmatism
pupil distance (mm)
时间窗: 1-day and within 2 weeks
pupil distance measurement with software or autorefractor
Spherical Equivalence(D)
时间窗: 1-day and within 2 weeks
Spherical is myopic equivalence with total spherical plus half the cylinder diopter.
Astigmatism Power(D)
时间窗: 1-day and within 2 weeks
Cylinder value of each total astigmatism power
次要结局
- Efficacy of test time (minutes)(1-day and within 2 eeks)