Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Normative Datasets
研究概览
简要总结
The goal of this clinical study is to collect standard data for the medical device neos™.
neos™ is a system that shows images and measures the resulting eye movements and pupil size.
Collecting standard data involves three steps. First it is checked if neos™ eye-tracking works well. Eye-tracking means recording where a person is looking. After that it is checked if participants look at the images shown in neos™ as planned. Finally the eye movements and the pupil size are measured. This is done in healthy volunteers including children and persons with eye and brain problems.
Participants in the study will wear a virtual reality headset. The screens in the headset will show different images. Cameras in the headset will record eye movements and pupil size. This will take about 15 minutes. During these 15 minutes the investigator looks at the following behaviors of the participants eyes:
- Where are the eyes looking
- How do the pupils react to light and darkness
- How do the eyes move
- How much can the participant see from the corner of their eyes
- How well are the eyes working together
详细描述
This is a post-market clinical investigation with the overall objective to collect normative data for neos™, including confirming the performance of the neos™ eye-tracking and the adequacy of the neos™visual stimuli.
This clinical investigation also has an exploratory component, looking at the presence of biomarkers in the neos™ examination results.
neos™ is a reusable medical device, that presents visual stimuli to both eyes individually, and measures the resulting eye movements and pupillary changes of each eye.
neos™ is indicated to quantitatively measure:
- The visual field
- Ocular alignment
- Afferent pupillary function
- Efferent pupillary function
- Smooth pursuit (eye movements)
- Saccades (eye movements)
- Gaze holding
- Fusional amplitude
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 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
Normative Datasets
时间窗: Single study visit - Day 0
The primery outcome of this post-market clinical investigation is not the testing of a hypothesis, but the collection of normative data for the diagnositic system neos™. Normative datasets consisting of Demographic information (age and sex, ethnicity) neos™ output data, i.e. the neos™ report, including the measurement data used to generate the report and data logs generated during the examination.
次要结局
- Accuracy and precision of pupil size(Single study visit - Day 0)
- Accuracy and precision of eye gaze direction(Single study visit - Day 0)
- Neuro-ophthalmological biomarkers(Within 30 days before single visit and 14 days after visit)
- Adequate stimuli(Single study visit - Day 0)
- Comparison of observed and expected biomarkers in ophthalmological and neurological Diseases(Within 14 days after single visit)
- neos™ biomarkers(Within 14 days after single visit)