Safety and Normative Data With Neos™

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

Participants will be recruited within three groups (including children, adolescents and adults):

• Healthy volunteers, meaning no known ophthalmological, neurological or vestibular disease
• Patients with ophthalmological diseases (e.g. strabismus, cataract, macular degeneration, central artery syndrome)
• Patients with neurological diseases (e.g. Small-Vessel White-Matter Disease, cerebellar ataxia, stroke, downbeat-nystagmus, vascular dementia, multiple sclerosis, M. Parkinson, M. Niemann-Pick type C, M. Alzheimer, galactosemia, schizophrenia, etc).

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:

• Age > 3
• Informed consent by participant and/or legal representative documented per signature
• Snellen visual acuity ≥ +0.1 LogMAR, with correction, on both eyes
• Refractive error between -10 and +5 diopters, on both eyes

Exclusion criteria

Healthy Volunteers:

• Known ophthalmological, neurological or vestibular disease
• Current medication/drugs that could potentially influence performance in ocular motor tasks and/or compliance in the judgement of the investigator (e.g. benzodiazepines, alcohol, or stimulants)
• Stimulative medication (e.g. with Ritalin®)
• Known substance abuse

Inclusion criteria

Patients:

• Age > 3
• Informed consent by participant and/or legal representative, designated trusted person or next of kin, documented per signature
• Refractive error between -10 and +5 diopters, on both eyes
• Known ophthalmological or neurological disease

Exclusion criteria

Patients:

• Visual acuity in one or both eyes < +1.3 LogMAR
• Incapacity to understand and comply with the examination in the opinion of the investigator (e.g. due to very advanced dementia, with failure to comply with easy experimental instructions and tasks)
• Known substance abuse