Collecting Safety and Standard Eye Movement Data Using Neos in Children, Healthy Adults, and Patients with Eye or Brain Conditions

What this Trial Is About

Researchers are evaluating the medical device neos193, which is designed to show images and measure eye movements and pupil size. This observational study aims to collect standard normative data and confirm the devices performance in tracking eye movements and presenting visual stimuli. The study also explores biomarkers detected by neos193 in healthy volunteers, including children, as well as patients with eye and brain diseases such as strabismus, cataract, multiple sclerosis, and Parkinsons disease. Participants will wear a virtual reality headset showing various images while cameras record eye movements and pupil size. The device measures several eye functions, including visual field, eye alignment, pupil responses, smooth pursuit, saccades, gaze holding, and fusional amplitude. The study includes three groups healthy volunteers across multiple age ranges starting from 3 years old, patients with eye diseases, and patients with neurological diseases. Each participant will have a single study visit lasting about 25 minutes, followed by a 15-day period to collect health record biomarkers. During the visit, researchers observe where the participants eyes look, how pupils react to light and darkness, eye movements, peripheral vision, and eye coordination. Data collected include normative datasets, accuracy and precision of eye gaze and pupil size measurements, and biomarkers related to neuro-ophthalmological conditions. The study monitors safety and collects follow-up biomarker data within 14 days after the visit. Total participation involves the single visit plus the follow-up period.

Safety and Normative Data With Neos™