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Safety and Normative Data With Neos™

Recruitingn/aAges 3 Years - anyAllmachineMD AG
NCT07258212 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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:

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

3 sites
machineMD AG
Bern, Switzerland
Inselspital, Bern university hospital
Bern, Switzerland
Onovis Augenpraxis
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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