Safety and Normative Data With Neos™
ConditionNeuro-Ophthalmology
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsormachineMD AG
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The recruitment of healthy volunteers will take place at medical and non-medical sites through advertisement. The recruitment of neurological and ophthalmic patients will take place at medical sites through the Principal Investigator.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Healthy volunteers
Group B: Neurological and ophthalmic patients
Trial outcomes
Primary outcomes
1
Normative Datasets
The primery outcome of this post-market clinical investigation is not the testing of a hypothesis, but the collection of normative data for the diagnositic system neos™. Normative datasets consisting of Demographic information (age and sex, ethnicity) neos™ output data, i.e. the neos™ report, including the measurement data used to generate the report and data logs generated during the examination.
Time frame
Single study visit - Day 0Secondary outcomes
1
Accuracy and precision of eye gaze direction
Accuracy and precision of eye gaze direction is calculated from the combination of measurement data and stimuli data applying the methodology described in "Tobii Technology (2011), Accuracy and precision test method for remote eye trackers, Test specification V.2.1.1; February 7th 2011" Will be estimated for the following participant groups * Healthy volunteers * Patients * As a function of interpupillary distance * Per age group
Time frame
Single study visit - Day 02
Accuracy and precision of pupil size
The accuracy and precision of pupil size is based on the recorded images of the eyes and the independent measurement of the iris diameter. Will be estimated for the following participant groups * Healthy volunteers * Patients * As a function of interpupillary distance * Per age group
Time frame
Single study visit - Day 03
Adequate stimuli
The confirmation of adequate visual stimuli is performed based on the neos™ report. The results presented in the report are assessed against predefined criteria. Adequacy of visual stimuli is reported as a proportion of participants, with 95% confidence interval, for which the adequacy of the visual stimuli was confirmed. Will be estimated for the following participant groups: * Healthy children (age younger than 13) * Healthy adolescents and adults (age older than 13) * Per age group
Time frame
Single study visit - Day 04
Neuro-ophthalmological biomarkers
Neuro-ophthalmological biomarkers present in the participants' medical records are collected. This is an exploratory outcome and will be reported in a frequency table.
Time frame
Within 30 days before single visit and 14 days after visitOther outcomes
1
Safety Outcome
Adverse events and adverse device effects, including any serious adverse events or serious adverse device effects.
Time frame
Single study visit - Day 0Sponsors and contacts
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Source ClinicalTrials.gov