Neuro-Ophthalmology
Conditions
Keywords
Virtual reality, Visual field, Ocular alignment, Afferent pupillary function, Efferent pupillary function, Smooth pursuit, Saccades, Gaze holding, Fusional amplitude, Normative data
Brief 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
Detailed description
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.
Interventions
None listed
Sponsors
machineMD AG
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normative Datasets | Single study visit - Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy and precision of eye gaze direction | Single study visit - Day 0 | 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 |
| Accuracy and precision of pupil size | Single study visit - Day 0 | 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 |
| Adequate stimuli | Single study visit - Day 0 | 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 |
| neos™ biomarkers | Within 14 days after single visit | The following biomarkers are expected to be identifiable in the neos™ report: Examination block 1: Gaze directions Gaze holding Ocular alignment Examination block 2: Pupillary function Efferent pupillary function Afferent pupillary function Examination block 3: Eye movements Saccades Smooth pursuit Examination block 4: Visual field Examination block 5: Fusional amplitude |
| Comparison of observed and expected biomarkers in ophthalmological and neurological Diseases | Within 14 days after single visit | For a set of pre-defined ophthalmological and neurological diseases, the presence of biomarkers in the neos™ measurements and in the health record is compared to the expected presence or frequency of biomarkers according to a pre-defined list of biomarkers. |
| Neuro-ophthalmological biomarkers | Within 30 days before single visit and 14 days after visit | Neuro-ophthalmological biomarkers present in the participants' medical records are collected. This is an exploratory outcome and will be reported in a frequency table. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome | Single study visit - Day 0 | Adverse events and adverse device effects, including any serious adverse events or serious adverse device effects. |
Countries
Switzerland
Contacts
Primary ContactPia Massatsch, PhD
Outcome results
None listed