Early Detection and Prevention of Amblyopia and Visual Impairment Through Systematic Pediatric Vision Screening
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity of a new amblyopia screening method compared to standard screening
研究概览
简要总结
Amblyopia, characterized by reduced visual acuity, develops in childhood due to insufficient sensory stimulation of the affected eye. It is the leading cause of low vision and loss of stereoscopic vision in both children and adults. Currently, 99 million people worldwide are affected, with recent projections indicating 222 million by 2040. Amblyopia can result from anisometropia (70%), strabismus (30%), or the presence of an ocular pathology (1%). Early management of these conditions (before the age of 7) can prevent the onset of amblyopia. Therefore, screening for these conditions is a major public health challenge to reduce the prevalence and associated costs of visual impairment.
The French-speaking Association of Strabology and Pediatric Ophthalmology (AFSOP) recommends systematic amblyopia screening for 3-year-old children. This screening involves measuring monocular visual acuity in both eyes (LEA chart at 3 meters), checking for strabismus (cover/uncover test), and performing a stereoscopic vision test (e.g., Lang I test).
Amblyopia is currently underdiagnosed for two main reasons: 1) it is often asymptomatic (75% of cases) and therefore cannot be detected without systematic screening; and 2) there is significant difficulty in accessing medical care in certain regions, and thus access to professionals capable of performing this screening (doctors, orthoptists). The difficulty in accessing healthcare professionals capable of screening for amblyopia in children aged 3 to 7 has already been raised.
We believe it would be beneficial to have an alternative screening method that is equivalent to the AFSOP-recommended method and accessible in areas with limited healthcare professionals. An eye-tracking system implemented in a virtual reality (VR) headset has recently been developed for monitoring eye movements. This system has shown effectiveness in rehabilitating visual field impairments in patients with traumatic brain injury. The system allows for remote monitoring of rehabilitation sessions, and data can be downloaded and viewed remotely via Wi-Fi.
The main objective of this study will be to estimate the sensitivity of the new VR-based eye-tracking screening method amblyopia screening method using an eye-tracking system implemented in a virtual reality headset compared to standard screening in children aged 3 to 7 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity of a new amblyopia screening method compared to standard screening
时间窗: At enrollment.
Sensitivity of a new amblyopia screening method using an eye-tracking system implemented in a virtual reality headset, compared to standard screening, in children aged 3 to 7 years. Sensitivity = (true positives) / (false negatives + true positives)
次要结局
- Specificity of the eye-tracking system compared to standard screening(At enrollment.)
- Sensitivity and specificity of the eye-tracking system compared to the same tests performed during standard screening(At enrollment.)
- Cover/uncover test for strabismus screening : angle of deviation(At enrollment.)
- Proportion of adverse events recorded during the diagnostic process(Day of the diagnostic examination (Day 1))
- Proportion of patients unable to complete the scheduled examination using the virtual reality headset(Day of the diagnostic examination (Day 1))
- Cover/uncover test for strabismus screening : direction(At enrollment)
- Cover/uncover test for strabismus screening : velocity(At enrollment)
