Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-03-07
2026-06-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Healthy volunteers
Healthy volunteers, meaning no known ophthalmological, neurological or vestibular disease.
The healthy volunteers are within the age groups: 3-6, 7-9, 10-12, 13-17, 18-29, 30-39, 40-49, 50-59, 60-69, 70-79, \>80.
No interventions assigned to this group
Neurological and ophthalmic patients
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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
3 Years
ALL
Yes
Sponsors
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machineMD AG
INDUSTRY
Responsible Party
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Principal Investigators
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Tatiana Bremova-Ertl, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inselspital
Locations
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machineMD AG
Bern, Canton of Bern, Switzerland
Inselspital, Bern university hospital
Bern, Canton of Bern, Switzerland
Onovis Augenpraxis
Bern, Canton of Bern, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Declaration of Helsinki, Version October 2013;
EN ISO 14155: Clinical investigation of medical devices for human participants - Good clinica00l practice, EN ISO 10993: Biological evaluation of medical devices, EN ISO 14971: Application of risk management to medical devices
Medical Device Regulation (EU) 2017/745
Tobii Technology (2011), Accuracy and precision test method for remote eye trackers, Test specification V.2.1.1; February 7th 2011
Other Identifiers
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CI-001
Identifier Type: -
Identifier Source: org_study_id
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