Safety and Normative Data With Neos™

Официальное название

Safety and Normative Data With Neos™, in Healthy Volunteers, Children and Patient Populations With Ophthalmological or Neurological Disease

Обзор

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

Подробное описание

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.

Первичные конечные точки

• Normative Datasets [Срок оценки: Single study visit - Day 0]

Вторичные конечные точки (6)

• Accuracy and precision of eye gaze direction [Срок оценки: Single study visit - Day 0]
• Accuracy and precision of pupil size [Срок оценки: Single study visit - Day 0]
• Adequate stimuli [Срок оценки: Single study visit - Day 0]
• Neuro-ophthalmological biomarkers [Срок оценки: Within 30 days before single visit and 14 days after visit]
• neos™ biomarkers [Срок оценки: Within 14 days after single visit]
• Comparison of observed and expected biomarkers in ophthalmological and neurological Diseases [Срок оценки: Within 14 days after single visit]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 3 центра

• machineMD AG — Bern
• Inselspital, Bern university hospital — Bern
• Onovis Augenpraxis — Bern

Идентификаторы

NCT: NCT07258212 · CI-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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