RecruitingNCT07258212

Safety and Normative Data With Neos™

Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease


Sponsor

machineMD AG

Enrollment

200 participants

Start Date

Mar 7, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 3 Years

Inclusion Criteria8

  • 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
  • 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 Criteria7

  • 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
  • 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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Locations(3)

machineMD AG

Bern, Canton of Bern, Switzerland

Inselspital, Bern university hospital

Bern, Canton of Bern, Switzerland

Onovis Augenpraxis

Bern, Canton of Bern, Switzerland

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NCT07258212


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