Neuro-Ophthalmologyneos-SNOWNCT07258212
Safety and Normative Data With Neos™
An observational study of Neuro-Ophthalmology, run by machineMD AG at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuro-Ophthalmology
- How many people
- 200 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 7 Mar 2024to Jun 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
machineMD AG
Bern, Canton of Bern, 3008
Pia Massatsch, PhD, +41 79 607 61 37, pia.massatsch@machinemd.com
- Recruiting
Inselspital, Bern university hospital
Bern, Canton of Bern, 3010
Tatiana Bremova-Ertl, MD, PhD, +41 31 632 70 00, tatiana.bremova-ertl@insel.ch
- Recruiting
Onovis Augenpraxis
Bern, Canton of Bern, 3011
Moritz Feil, Dr med, +41 31 311 15 55, moritz.feil@hin.ch
About this study
Official title: Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease
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.
Read more
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
Read the 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.
- Conditions
- Neuro-Ophthalmology
- Keywords
- Virtual reality, Visual field, Ocular alignment, Afferent pupillary function, Efferent pupillary function, Smooth pursuit, Saccades, Gaze holding, Fusional amplitude, Normative data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single study visit - Day 0
Secondary outcomes (6)
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
Measured: 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
- Healthy volunteers
- Patients
- As a function of interpupillary distance
- Per age group
Measured: 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:
- Healthy children (age younger than 13)
- Healthy adolescents and adults (age older than 13)
- Per age group
Measured: 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.
Measured: 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
Measured: 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.
Measured: Within 14 days after single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start7 Mar 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-OphthalmologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- machineMD AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tatiana Bremova-Ertl, MD, PhD, Principal investigator, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258212
- Sponsor's protocol ID
- CI-001
- Acronym
- neos-SNOW
- Status last verified
- Nov 2025
- First submitted
- 27 Oct 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease
- ClinicalTrials.gov ID
- NCT07258212
- Acronym / sponsor ID
- neos-SNOW / CI-001
- Conditions
- Neuro-Ophthalmology
- Keywords
- Virtual reality, Visual field, Ocular alignment, Afferent pupillary function, Efferent pupillary function, Smooth pursuit, Saccades, Gaze holding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- machineMD AGIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normative Datasets
Time frame: 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.
6 secondary outcomes
Accuracy and precision of eye gaze direction
Time frame: Single study visit - Day 0
Accuracy and precision of pupil size
Time frame: Single study visit - Day 0
Adequate stimuli
Time frame: Single study visit - Day 0
Neuro-ophthalmological biomarkers
Time frame: Within 30 days before single visit and 14 days after visit
neos™ biomarkers
Time frame: Within 14 days after single visit
Comparison of observed and expected biomarkers in ophthalmological and neurological Diseases
Time frame: Within 14 days after single visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Declaration of Helsinki, Version October 2013;Link provided by the sponsor.
- Medical Device Regulation (EU) 2017/745Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tatiana Bremova-Ertl, MD, PhD principal investigator
Inselspital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-Ophthalmology, run by machineMD AG at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pia Massatsch, PhD (+41 79 607 61 37, pia.massatsch@machinemd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normative Datasets (time frame: Single study visit - Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.