Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001150639p
Ethics application status
Submitted, not yet approved
Date submitted
6/10/2023
Date registered
7/11/2023
Date last updated
7/11/2023
Date data sharing statement initially provided
7/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A validation study to evaluate performance and safety of the BioEye application
Scientific title
single-centre, validation study to evaluate the preliminary performance and safety
of measuring Smooth Pursuit (SMP) and Pupillary Light Reflex (PLR) ocular
biomarkers using the BioEye application
Secondary ID [1] 310750 0
646/23
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinsonism 331706 0
Multiple Sclerosis 331839 0
Dementia 331840 0
Epilepsy 331841 0
Condition category
Condition code
Neurological 328444 328444 0 0
Parkinson's disease
Neurological 328580 328580 0 0
Multiple sclerosis
Neurological 328581 328581 0 0
Dementias
Neurological 328582 328582 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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. BioEye 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 BioEye device 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, BioEye 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 BioEye 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 BioEye 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, Caulfield.
Intervention code [1] 327161 0
Behaviour
Comparator / control treatment
Control group participants (neurologically healthy individuals) will undergo the same tesing protocol as those with a neurologicla condtion. Specifically, over a single testing session smooth pursuit eye movements and the pupillary light reflex will be measured using the BioEye 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 BioEye 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, Caulfield.
Control group
Active

Outcomes
Primary outcome [1] 336284 0
The accuracy of the BioEye application’s measure of smooth pursuit latency will be determined by comparison with measures obtained using the Eyelink and Tobii systems
Timepoint [1] 336284 0
Assessed at the end of all testing.
Primary outcome [2] 336389 0
The accuracy of the BioEye application’s measure of smooth pursuit accuracy will be determined by comparison with measures obtained using the Eyelink and Tobii systems.
Timepoint [2] 336389 0
Assessed at the end of all testing.
Primary outcome [3] 336471 0
The accuracy of the BioEye application’s measure of pupillary light reflex will be determined by comparison with measures obtained using the Neuroptics pupillometer
Timepoint [3] 336471 0
Assessed at the end of all testing.
Secondary outcome [1] 427658 0
Usability of the BioEye application
Timepoint [1] 427658 0
During testing session
Secondary outcome [2] 427659 0
Safety of the BioEye application - there are currently no known or anticipated adverse reaction/events possible using the BioEye application
Timepoint [2] 427659 0
During testing session

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Baseline characteristics, concomitant medication, and subject disposition will be summarized descriptively. CCC and 95% CI will be calculated between each BioEye application vs gold standard measure separately for each study cohort. CCC is an index of agreement with the range between -1 and +1 - values near +1 will indicate strong concordance between the two devices, values near -1 will indicate strong discordance, and values near zero will indicate no concordance.

Pearson correlation coefficients and 95% CIs will also be calculated. Paired t-tests will be used to compare the systematic differences between BioEye application measures and gold standard measures for each study cohort. Bland and Altman plots will also be used to assess agreement between BioEye application and gold standard measures for each study cohort, with limits of agreement and average differences (bias) between BioEye application and gold standard measures plotted for inspection.

Measures acquired for neurologically healthy volunteers and participants with a neurological condition will be compared by a t-test separately for gold standard measures and for BioEye application measures. This is to assess whether the differences between groups observed by the gold standard can also be observed by the BioEye application.

Safety data will be summarized descriptively and listed if any data are reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25710 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41534 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 314981 0
Commercial sector/Industry
Name [1] 314981 0
BioEye Pty Ltd
Country [1] 314981 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
BioEye Pty Ltd
Address
The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country
Australia
Secondary sponsor category [1] 316987 0
None
Name [1] 316987 0
Address [1] 316987 0
Country [1] 316987 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313954 0
Alfred Hospital Ethics Committee.
Ethics committee address [1] 313954 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 313954 0
Australia
Date submitted for ethics approval [1] 313954 0
06/10/2023
Approval date [1] 313954 0
Ethics approval number [1] 313954 0

Summary
Brief summary
BioEye is an Australian company that has developed a proprietary eye-tracking platform, using an application via a smartphone, to assess brain function.
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. BioEye 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, BioEye 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 BioEye measures of latency, velocity, amplitude and accuracy will correlate significantly with gold standard device measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129910 0
A/Prof Joanne Fielding
Address 129910 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129910 0
Australia
Phone 129910 0
+61 414883541
Fax 129910 0
Email 129910 0
joanne.fielding@bioeye.com
Contact person for public queries
Name 129911 0
A/Prof Joanne Fielding
Address 129911 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129911 0
Australia
Phone 129911 0
+61 414883541
Fax 129911 0
Email 129911 0
joanne.fielding@bioeye.com
Contact person for scientific queries
Name 129912 0
A/Prof Joanne Fielding
Address 129912 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129912 0
Australia
Phone 129912 0
+61 414883541
Fax 129912 0
Email 129912 0
joanne.fielding@bioeye.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is commercially sensitive i.e., used for the development/refinement of a commercial product.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20619Study protocol    Not available yet



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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