Study of the Subjective Refraction Measured With SiVIEW Software Compared to That Obtained Manually by an Expert. Monocentric Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SiVIEW
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Equivalent sphere measurement
研究概览
简要总结
Main objective
Show that the equivalent sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Secondary objectives
Show that the sphere refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the cylinder refraction measurements obtained by the SiVIEW software have no significant clinical difference with those obtained by an optometrist expert.
Show that the visual acuity measurements obtained by the SiVIEW software do not have a significant clinical difference with those obtained by an optometrist expert.
Demonstrate that the report delivered for each eye exam by SiVIEW software is consistent and relevant to a vision health practitioner.
Show that the differences obtained between two eye examination experts are consistent with those found in the literature.
详细描述
Introduction:
Ametropia is an eye refractive disorder typically leading to myopia, hyperopia, astigmatism... 4.5 billion people are currently affected worldwide, of whom only 2 billion are corrected. Of these people, about 30% (or +/- 600,000) do not benefit from an adequate correction. From an economic point of view, the cost on productivity of the absence or poor vision correction is estimated at more than 270 billion euros / year worldwide.
Any correction of an ametropic disorder necessarily requires a precise and relevant eye examination in order to identify the disorder and determine the best possible visual correction. The procedure for this examination is identical in all countries. It must follow specific steps[Benjamin 2006; Grosvenor 2007].
At present the refraction measurement is done manually by an expert. The optical correction may vary from one examination to another, for multiple physiological and/or examination-related reasons. Several factors can cause fluctuations in subjective refraction. These include examiner and subject characteristics [Grein et al. 2014].
In addition, there is also variability due to the measurement itself, depending on each examiner. The repeatability (on the same subject) and, in addition, the reproducibility (inter-examiners) of the subjective refraction measurement related to the examiner's interpretation, examination process and experience, among other things, are therefore important data to be defined in order to know the tolerance of the measurement determined between two examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subject with visual AV on each eye >= 8/10 and no amblyopia
- •subject with normal environmental transparency
- •subject with a healthy fundus that does not reveal major abnormalities that may affect vision
- •subject able to read the letters of the Latin alphabet
- •subject without heavy drug treatment that may affect vision as synthetic antimalarials, corticosteroids
- •non-diabetic subject
- •non nystagmic subject
- •non-strabic 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)
结局指标
主要结局
Equivalent sphere measurement
时间窗: At time of inclusion
The subject will have an eye exam with SiVIEW and an examination by an optometrist expert. The equivalent sphere value will be evaluated in both cases.
次要结局
- Cylinder measurement(At time of inclusion)
- Visual acuity(At time of inclusion)
- Sphere measurement(At time of inclusion)
- Consistency and relevance of the SiVIEW report(At time of inclusion)
- Measurement between two optometrist experts(At time of inclusion)