Evaluation of the Photorefraction Screener Snapsight in Comparison With Cycloplegia Table-top Autorefractor in Ametropia in Pediatric Population Between 3 and 8yo, Multicenter French Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Perfomance evaluation for ametropia screening
研究概览
简要总结
The goal of this clinical trial is to evaluate the performance of a photorefraction screener in terms of sensibility, sensitivity and accuracy on children aged 3 to 8 y.o. The main objectives of the study are:
- Evaluate the performances of the device in comparison with the gold standard, i.e. a tabletop refractometer.
- Assess the agreement of the measures obtained with the device with those obtained with the gold standard.
详细描述
Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 3-8 years when included in the study
- •All skin phototypes (I to VI according to the Fitzpatrick classification)
- •Wearing glasses or not
- •Capacity to give valid consent
- •Capacity to follow the protocol to obtain reliable measure
- •Under French medical insurance
排除标准
- •Under myopia control solution that may have an impact on refractive error (such as: atropine, orthokeratology,..)
- •Wearing contact lenses
- •Ocular or systemic pathology that may have an impact on vision or may interfere with the study measures (except strabismus)
- •Under medication that may have an impact on vision or may interfere with study measurements
- •Known contraindication to the active substance or to one of the excipients of eye drops (Mydriaticum 0.5%, Skiacol 0.5%)
- •Known risk of angle-closure glaucoma
- •Participation to another study that may have an impact on vision or may interfere with the study measures
研究组 & 干预措施
Snapsight photorefraction device
干预措施: Photorefraction device under investigation (Device)
Snapsight photorefraction device
干预措施: Comparator device, Tabletop auto-refractometer (Device)
Snapsight photorefraction device
干预措施: Comparator device, portable photorefraction device (Device)
Snapsight photorefraction device
干预措施: Distance visual acuity assessments (Other)
Snapsight photorefraction device
干预措施: Subjective refraction and far visual acuity (Other)
Snapsight photorefraction device
干预措施: Strabismus assessment (Other)
结局指标
主要结局
Perfomance evaluation for ametropia screening
时间窗: One day (all measurements are taken during a single evaluation visit).
The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer.
次要结局
- Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer(One day (all measurements are taken during a single evaluation visit).)
- Perfomance evaluation for ametropia screening(One day (all measurements are taken during a single evaluation visit).)
- Perfomance evaluation for amblyopia screening(One day (all measurements are taken during a single evaluation visit).)
- Safety assessment and device failures(One day (all measurements are taken during a single evaluation visit).)