Neos™ virtual-reality test for measuring eye movements and pupil responses
Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease
This test uses a VR headset (neos™) to record where your eyes look and how your pupils react in healthy volunteers and people with eye or brain conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | machineMD AG Industry-sponsored |
| Locations | 3 sites (Bern, Canton of Bern and 2 other locations) |
| Trial ID | NCT07258212 on ClinicalTrials.gov |
What this trial studies
The neos™ system presents visual stimuli to each eye inside a virtual-reality headset while cameras record eye position and pupil size. The visit is short (about 15 minutes of recording within a ~25-minute visit) and includes healthy volunteers as well as patients with ophthalmological or neurological conditions, including children and adults. The primary aim is to collect normative data and confirm that the neos™ eye-tracking and stimuli perform as intended. The study also includes an exploratory component to look for potential biomarkers in the eye movement and pupillary data.
Who should consider this trial
Good fit: Ideal candidates are people aged over 3 who can give informed consent (or have a legal representative), have refractive error within −10 to +5 diopters, and are either healthy volunteers or have a known ophthalmological or neurological condition.
Not a fit: Patients with very poor vision (worse than about +1.3 LogMAR), those taking medications that affect ocular motor performance, or those with refractive error outside the allowed range are unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, the study could provide normative reference data and validate a quick VR-based tool to measure visual fields, ocular alignment, eye movements, and pupil function for diagnosis and monitoring.
How similar studies have performed: Similar approaches using VR and eye-tracking have shown promise for measuring visual fields and eye movements in research settings, but large normative datasets across ages remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria Patients: * 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
Where this trial is running
Bern, Canton of Bern and 2 other locations
- machineMD AG — Bern, Canton of Bern, Switzerland (Recruiting)
- Inselspital, Bern university hospital — Bern, Canton of Bern, Switzerland (Recruiting)
- Onovis Augenpraxis — Bern, Canton of Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Tatiana Bremova-Ertl, MD, PhD — Inselspital
- Study coordinator: Pia Massatsch, PhD
- Email: pia.massatsch@machinemd.com
- Phone: +41 79 607 61 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.