Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001151628
Ethics application status
Approved
Date submitted
6/10/2023
Date registered
7/11/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
7/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the utility of BioEye eye-tracking technology in managing neurological conditions
Scientific title
A single-arm, Pivotal Study to determine safety, usability and performance ofscreening ocular biomarkers in participants with a neurological condition using theBioEye application
Secondary ID [1] 310751 0
468/23
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinsonism (i.e., Parkinson's and other types of Parkinsonism inlcuding Progressive Supranuclear Palsy, Multiple Systems Atrophy) 331707 0
Multiple Sclerosis 331836 0
Dementia 331837 0
Epilepsy 331838 0
Condition category
Condition code
Neurological 328445 328445 0 0
Parkinson's disease
Neurological 328576 328576 0 0
Multiple sclerosis
Neurological 328577 328577 0 0
Dementias
Neurological 328578 328578 0 0
Epilepsy
Neurological 328579 328579 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neurological disorders are the leading cause of disability world-wide. Due to our aging population and population growth, this burden will inevitably increase over time. To add to this burden, our capacity to detect and treat many neurological disorders is hampered not only by gaps in our knowledge but by a lack of appropriate and cost-effective biomarkers to measure and monitor change in function. The study of eye movements is an established and widely used methodology in experimental research, the assessment of eye movements already an integral part of the clinical examination with distinctive eye movements characteristic of almost all neurological conditions. However, eye movements cannot currently be measured with precision outside of the research setting.

This research aims to establish the utility of the BioEye eyetracking application in measuring aberrant function in some of the most common neurological diseases. By measuring simple eye movement parameters in patients with various neurological conditions we will ascertain whether the application can be used to dissociate individuals with a neurological condition from individuals without a neurological condition (specifically, by using smooth pursuit and pupillary light reflex ocular markers). Beyond this study, this may help to determine whether the BioEye applcation can provide a safe and simple measure of change in neurological function over time.

The researchers will test all participants once, within their neurology clinic at the Alfred Hospital using the BioEye application on a (BioEye) smartphone. To measure smooth pursuit eye movements participants will be asked to follow a dot moving in a circle across the screen of the smartphone. To measure the pupillary light reflex, the BioEye application will use the smartphone flash to illuminate the participants eyes for 3 seconds. Testings sessions will take no longer than 5 minutes (including delivery of instructions).
Intervention code [1] 327162 0
Diagnosis / Prognosis
Comparator / control treatment
Neurologically healthy controls will undergo the same testing procedure as participants with a neurological disorder. Either within the Alfred Hospital or a place of the participant's choosing the researchers will test all participants once, using the BioEye application on a (BioEye) smartphone. To measure smooth pursuit eye movements participants will be asked to follow a dot moving in a circle across the screen of the smartphone. To measure the pupillary light reflex, the BioEye application will use the smartphone flash to illuminate the participants eyes for 3 seconds. Testings sessions will take no longer than 5 minutes (including delivery of instructions).
Control group
Active

Outcomes
Primary outcome [1] 336285 0
Latency measure for smooth pursuit eye movements
Timepoint [1] 336285 0
This measure is determined in real time, at the time of testing.
Primary outcome [2] 336472 0
Accuracy measures for smooth pursuit eye movements
Timepoint [2] 336472 0
These measures are determined in real time, at the time of testing.
Primary outcome [3] 336473 0
Constriction measures for the pupillary light reflex
Timepoint [3] 336473 0
These measures are determined in real time, at the time of testing.
Secondary outcome [1] 428120 0
Determination of whether data from neurologically healthy individuals can be dissociated from data from those with a neurological condition
Timepoint [1] 428120 0
At end of all testing

Eligibility
Key inclusion criteria
• Diagnosis of a medical condition directly impacting the integrity of the Central Nervous System (patients only)
• No evidence of a medical condition directly impacting the integrity of the Central Nervous System (healthy individuals only)
• Aged 18 years or over
• Eligible to receive Medicare
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Co-occurrence of more than one neurological condition (patients only)
• Any neurological condition (healthy individuals only)
• Unable to communicate adequately for whatever reason based on informal clinical judgment by the clinical staff member regarding the patient’s ability to follow instructions needed to perform the test and understand the consent process (patients only).
• Subjectively unable to see a 3mm object at a distance of 10 cm

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
Efficacy
Statistical methods / analysis
Statistical methods will align with the development of commercially viable algorithms suitable for identifying change in neurological function. These standard methods will variously include score adjustment for extraneous factors, normalisation/standardisation of scores, principal components analyses, regression analyses, and algorithm development.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2025
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25711 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41535 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 314982 0
Commercial sector/Industry
Name [1] 314982 0
BioEye Pty Ltd
Country [1] 314982 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] 316989 0
None
Name [1] 316989 0
Address [1] 316989 0
Country [1] 316989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313955 0
Alfred Hospital Ethics Committee.
Ethics committee address [1] 313955 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 313955 0
Australia
Date submitted for ethics approval [1] 313955 0
24/08/2023
Approval date [1] 313955 0
30/10/2023
Ethics approval number [1] 313955 0

Summary
Brief summary
Neurological disorders are the leading cause of disability world-wide. Due to our aging population and population growth, this burden will inevitably
increase over time. To add to this burden, our capacity to detect and treat many neurological disorders is hampered not only by gaps in our knowledge but
by a lack of appropriate and cost-effective biomarkers to measure and monitor change in function. The study of eye movements is an established and
widely used methodology in experimental research, the assessment of eye movements already an integral part of the clinical examination with distinctive
eye movements characteristic of almost all neurological conditions. However, eye movements cannot currently be measured with precision outside of the
research setting. This research aims to establish the utility of the BioEye eyetracking application in measuring aberrant function in some of the most
common neurological diseases. By measuring simple eye movement parameters in patients with various neurologic conditions we will ascertain WHETHER
the application can be used by the individual to self monitor change or by a physician to monitor change in function and adjust or implement treatments at
the earliest possible timepoint.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129914 0
A/Prof Joanne Fielding
Address 129914 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129914 0
Australia
Phone 129914 0
+61 414883541
Fax 129914 0
Email 129914 0
joanne.fielding@bioeye.com
Contact person for public queries
Name 129915 0
A/Prof Joanne Fielding
Address 129915 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129915 0
Australia
Phone 129915 0
+61 414883541
Fax 129915 0
Email 129915 0
joanne.fielding@bioeye.com
Contact person for scientific queries
Name 129916 0
A/Prof Joanne Fielding
Address 129916 0
BioEye Pty Ltd, The Commons Sydney Central, 20-40 Meagher St, Chippendale, NSW, 2008
Country 129916 0
Australia
Phone 129916 0
+61 414883541
Fax 129916 0
Email 129916 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
20620Study protocol    Not available yet



Results publications and other study-related documents

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