None listed
Conditions
Brief summary
Neuro Optica is an Australian company that has developed a proprietary eye-tracking platform, using an application via a smartphone, to assess brain function (BrainEye). The application is currently categorised as a wellness device (non-medical) and as such does not fall under the Therapeutic Goods Administration as regulated under the Therapeutic Goods Act. Accordingly, fundamental research studies of the application have not been conducted to Good Clinical. Practice (GCP) or ISO 14155 standards. Neuro Optica is now proposing that the device be classified as a low risk SaMD (Class 1 medical device), capable of measuring and analysing ocular movements, although with results used for information only, i.e., not for clinical diagnosis. Although clinical trials are not required to support this proposal, Neuro Optica wish to substantiate its labelling claims to the market by conducting a clinical trial on a small number of participants (n=30), validating its smooth pursuit and pupillary light reflex measures against gold standard device measures. We hypothesis that all BrainEye measures of latency, velocity, amplitude and accuracy will correlate significantly with gold standard device measures.
Interventions
Eye movements have been used for decades to interrogate neurological function, and we have an extensive understanding of the consequences of a broad range of neurological disorders on eye movements. BrainEye is a smartphone application that uses AI, machine learning, and cloud based technology to record and anlayse the location of the eye in space over time, with a view to providing a snapshot of neurological function in an individual over time.
The BrainEye application is classified as a low r
Eye movements have been used for decades to interrogate neurological function, and we have an extensive understanding of the consequences of a broad range of neurological disorders on eye movements. BrainEye is a smartphone application that uses AI, machine learning, and cloud based technology to record and anlayse the location of the eye in space over time, with a view to providing a snapshot of neurological function in an individual over time. The BrainEye application is classified as a low risk SaMD (Class 1 medical device), capable of measuring and analysing ocular movements, although with results used for information only, i.e., not for clinical diagnosis. Although clinical trials are not required to support this proposal, Neuro Optica will substantiate its labelling claims to the market by conducting a clinical trial on a small number of participants (n=30), validating its smooth pursuit and pupillary light reflex measures against gold standard measures. This study will be conducted to GCP and ISO 14155 standards under the Clinical Trial Notification (CTN) scheme. Specifcally, over a single testing session smooth pursuit eye movements and the pupillary light reflex will be measured using the BrainEye application on a smartphone as well as three gold standard devices. These devices are the Neuroptic NPI Pupillometer (to measure the pupillary light reflex) and the EyeLink portable Duo video-oculography system and Tobii Pro Glasses 3 (to meaure smooth pursuit eye movements). To measure the pupillary light reflex a flash of light will be delivered to the participants eyes, and to measure smooth pursuit eye movements, participants will be asked to fixate and/or follow a moving dot across the smartphone screen for the BrainEye applicaton or a computer screen for EyeLink and Tobii systems. Testing will take no longer than 45 minutes and will be conducted at Monash University, Alfred Centre.
Sponsors
Neuro Optica Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Healthy volunteer or diagnosis of a neurological condition ( Parkinson's, Multiple slerosis, dementia, epilepsy) • Age 18 years or over • Written informed consent prior to participation • Able to verbally communicate well with the investigator, to understand and comply with the requirements of the study • If female, not pregnant or breast feeding
Exclusion criteria
• History of cognitive deficit • History of attention deficit disorder • Previously diagnosed concussion (within the past year) • History of intracranial disease • History of unresolved strabismus, diplopia, amblyopia • History of unresolved cranial nerve III, IV or VI palsy • History of unresolved macular oedema, retinal degeneration, extensive cataract, or ocular globe disruption • History of unresolved extensive corneal surgery or scarring • Lack of two functional eyes • Unresolved ocular motor dysfunction • Obvious intoxication or impairment that limits ability to participate • Imaging abnormality (i.e., fracture or bleed) • Unable to come in for follow-up visits • Any medical condition which, in the view of the Investigator, is likely to interfere with the study or put the participant at risk • Currently enrolled in another clinical study
Outcome results
None listed