Safety and Normative Data With Neos™

NCT07258212 | Recruiting

• 1 other identifier: CI-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

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.

  Single study visit - Day 0

Secondary Outcomes (6)

• Accuracy and precision of eye gaze direction

  Single study visit - Day 0

• Accuracy and precision of pupil size

  Single study visit - Day 0

• Adequate stimuli

  Single study visit - Day 0

• Neuro-ophthalmological biomarkers

  Within 30 days before single visit and 14 days after visit

• neos™ biomarkers

  Within 14 days after single visit

Other Outcomes (1)

• Safety Outcome

  Single study visit - Day 0

Study Arms (2)

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).

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• machineMD AG: lead

Study Sites (3)

machineMD AG

Bern, Canton of Bern, 3008, Switzerland

RECRUITING

Inselspital, Bern university hospital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Onovis Augenpraxis

Bern, Canton of Bern, 3011, Switzerland

RECRUITING

Related Links

• 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

Study Officials

• Tatiana Bremova-Ertl, MD, PhD

  Inselspital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pia Massatsch, PhD

CONTACT

+41 79 607 61 37; pia.massatsch@machinemd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: December 2, 2025
• Study Start: March 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CH (3)