Safety and Normative Data With Neos™

Condition(s) studied

Study summary

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

Eligibility

Primary outcome measure(s)

• Normative Datasets — 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.

Trial sites (3)