Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000221651p
Ethics application status
Not yet submitted
Date submitted
14/02/2023
Date registered
2/03/2023
Date last updated
15/10/2023
Date data sharing statement initially provided
2/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysis of features of eye gaze useful in the diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.
Scientific title
A comparative clinical study of features of eye gaze for the diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.
Secondary ID [1] 308937 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 328944 0
Condition category
Condition code
Neurological 325932 325932 0 0
Parkinson's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Analysis of features of eye gaze for the diagnosis of Parkinson's disease (PD). A commercial eye tracker (GP3-HD, Gazepoint Canada) will be used to collect data. The device is attached to a laptop screen and placed approximately 65 cm from the participant's eyes. Data are collected face-to-face. For PD patients, data will be collected from a private neurology clinic in Dandenong and from a participating hospital (Goulburn Valley Health), Victoria. For healthy controls, data will also be collected at RMIT University and a community setting in Rye, Victoria.
Participants will be requested to look at a red filled circle (about 1 cm diameter) centred in the middle of the computer screen. The pupillary light reflex (PLR) is stimulated using different background colours. Participants will first look at the red filled circle with a black background for 20 seconds and then with a white background colour for a further 20 seconds. Participants will sit comfortably in front of the computer screen in an office room with ambient light.
The second experiment will collect data using the same commercial eye tracker but for this experiment the experiment measures saccadic eye movements. Here the red filled circle moves horizontally and randomly from one edge of the screen to the other. Participants are asked to follow the red filled circle with their eyes only (no head movement). The duration of this second experiment is approximately 2 minutes.
The total time commitment for participants is approximately 15 minutes. All experiments are conducted by the researchers from the School of Engineering, RMIT University.
Intervention code [1] 325382 0
Early Detection / Screening
Intervention code [2] 325383 0
Diagnosis / Prognosis
Comparator / control treatment
Healthy age-matched controls will complete the same 2 experiments using the same equipment as above.
Control group
Active

Outcomes
Primary outcome [1] 333777 0
Assessment of pupillary light reflex (hippus) using the commercial eye tracker (GP3-HD, Gazepoint Canada)
Timepoint [1] 333777 0
Assessed after single eye gaze assessment session
Primary outcome [2] 333962 0
Assessment of saccades using the commercial eye tracker (GP3-HD, Gazepoint Canada).
Timepoint [2] 333962 0
Assessed after single eye gaze assessment session
Secondary outcome [1] 418271 0
Nil
Timepoint [1] 418271 0
Nil

Eligibility
Key inclusion criteria
1.People diagnosed with Parkinson's disease, as evidenced by Unified Parkinson's disease Rating Scale (UPDRS) scores consistent with minimal to moderate disease
2.Healthy age-matched controls
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For Parkinson''s disease participants - diagnosed with other neurodegenerative diseases or stroke; cognitive impairment as evidenced by Montreal Cognitive Assessment (MoCA) score less than 26/30

For healthy controls - diagnosis of any neurodegenerative disease or stroke

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Sample size is calculated using a small effect size of 0.35 based on a previous study reported reported by our team (1.).
Statistical methods used for evaluation will be based on group differences (Independent-samples-t test / MANOVA or non parametric equivalent as required).

1. Ngo, Q. C., Bhowmik, S., Sarossy, M., & Kumar, D. K. (2021). Pupillary Complexity for the Screening of Glaucoma. IEEE Access, 9, 144871-144879

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/11/2023
Actual
Date of last participant enrolment
Anticipated
20/11/2026
Actual
Date of last data collection
Anticipated
20/11/2026
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39543 0
3001 - Melbourne
Recruitment postcode(s) [2] 39545 0
3175 - Dandenong
Recruitment postcode(s) [3] 39544 0
3631 - Shepparton North
Recruitment postcode(s) [4] 39546 0
3941 - Rye

Funding & Sponsors
Funding source category [1] 313148 0
University
Name [1] 313148 0
RMIT University
Country [1] 313148 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
GPO Box 2476, Melbourne VIC 3001 Australia
Country
Australia
Secondary sponsor category [1] 314850 0
None
Name [1] 314850 0
Address [1] 314850 0
Country [1] 314850 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312389 0
RMIT HREC
Ethics committee address [1] 312389 0
GPO Box 2476, Melbourne VIC 3001 Australia
Ethics committee country [1] 312389 0
Australia
Date submitted for ethics approval [1] 312389 0
11/10/2023
Approval date [1] 312389 0
Ethics approval number [1] 312389 0

Summary
Brief summary
Eye movement abnormalities including the pupillary light reflex (PLR) and saccades occur in movement disorders including Parkinson’s disease. The purpose of this study is to identify robust features of eye gaze as demonstrated using a commercial eye tracking device that may be used to identify and assess eye movement abnormalities in Parkinson’s disease patients and those at risk of developing Parkinson’s disease. The ultimate aim of this work is to develop an automated diagnostic tool for the diagnosis and assessment of eye gaze abnormalities for people living in rural and remote communities. Patients will be able to record their eye gaze under specified conditions. The recordings will be analysed and eye gaze and analysis sent to a specialist physician.
The aim of this study is to ascertain features of the PLR and saccades that are most useful in identifying differences between Parkinson’s disease patients and healthy age-matched controls using a commercially available eye tracker. The hypothesis is that Parkinson’s disease patients will exhibit significantly different eye gaze features compared with healthy age-matched controls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124490 0
Prof Dinesh Kumar
Address 124490 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124490 0
Australia
Phone 124490 0
+61 399251954
Fax 124490 0
Email 124490 0
dinesh.kumar@rmit.edu.au
Contact person for public queries
Name 124491 0
Prof Dinesh Kumar
Address 124491 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124491 0
Australia
Phone 124491 0
+61 399251954
Fax 124491 0
Email 124491 0
dinesh.kumar@rmit.edu.au
Contact person for scientific queries
Name 124492 0
Prof Dinesh Kumar
Address 124492 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124492 0
Australia
Phone 124492 0
+61 399251954
Fax 124492 0
Email 124492 0
dinesh.kumar@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Saved data will not be identifiable except for participant grouping (healthy or Parkinson's disease)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18270Study protocol    Directly from researchers conducting the study
18271Informed consent form    Directly from researchers conducting the study
18272Ethical approval    Directly from researchers conducting the study



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.