Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease
Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease
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:
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:
Participants will be recruited within three groups (including children, adolescents and adults):
The approximate duration of the single study visit is 25 minutes, not taking the time for patient information and informed consent into account. A follow up period of 15 days exists for the collection of biomarkers recorded in the participant's health record.
The direct clinical benefit from participating in this clinical investigation is the additional information provided by the neos™ examination.
Inclusion Criteria Healthy Volunteers:
Exclusion Criteria Healthy Volunteers:
Inclusion Criteria Patients:
Exclusion Criteria Patients:
pia.massatsch@machinemd.com+41 79 607 61 37
tatiana.bremova-ertl@insel.ch+41 31 632 70 00
moritz.feil@hin.ch+41 31 311 15 55