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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:
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:
Participants will be recruited within three groups (including children, adolescents and adults):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Single study visit - Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome | Adverse events and adverse device effects, including any serious adverse events or serious adverse device effects. | Single study visit - Day 0 |
Inclusion Criteria Healthy Volunteers:
Exclusion Criteria Healthy Volunteers:
Inclusion Criteria Patients:
Exclusion Criteria Patients:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pia Massatsch, PhD | Contact | +41 79 607 61 37 | pia.massatsch@machinemd.com |
| Name | Affiliation | Role |
|---|---|---|
| Tatiana Bremova-Ertl, MD, PhD | Inselspital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| machineMD AG | Recruiting | Bern | Canton of Bern | 3008 | Switzerland |
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| Label | URL |
|---|---|
| Declaration of Helsinki, Version October 2013; | View source |
| 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 | View source |
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| Single study visit - Day 0 |
| 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
| Single study visit - Day 0 |
| 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:
| Single study visit - Day 0 |
| 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. | Within 30 days before single visit and 14 days after visit |
| neos™ biomarkers | 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 | Within 14 days after single visit |
| Comparison of observed and expected biomarkers in ophthalmological and neurological Diseases | 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. | Within 14 days after single visit |
| Inselspital, Bern university hospital | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
|
| Onovis Augenpraxis | Recruiting | Bern | Canton of Bern | 3011 | Switzerland |
|
| Medical Device Regulation (EU) 2017/745 | View source |
| Tobii Technology (2011), Accuracy and precision test method for remote eye trackers, Test specification V.2.1.1; February 7th 2011 | View source |