Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000222640p
Ethics application status
Not yet submitted
Date submitted
14/02/2023
Date registered
2/03/2023
Date last updated
2/03/2023
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 Glaucoma for people living in rural and remote communities. A comparative study between people with early to mid-stage Glaucoma and age-matched healthy volunteers.
Scientific title
A comparative clinical study of features of eye gaze for the diagnosis of Glaucoma for people living in rural and remote communities. A comparative study between people with early to mid-stage Glaucoma and age-matched healthy volunteers.
Secondary ID [1] 308938 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
glaucoma 328947 0
Condition category
Condition code
Eye 325933 325933 0 0
Diseases / disorders of the eye

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 Glaucoma. 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 glaucoma patients, data will be collected from a private ophthalmology clinic in Essendon, Victoria. For healthy controls, data will be collected at RMIT University or in 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] 325384 0
Early Detection / Screening
Intervention code [2] 325385 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] 333781 0
Assessment of pupillary light reflex (hippus) using the commercial eye tracker (GP3-HD, Gazepoint Canada).
Timepoint [1] 333781 0
Assessed after single eye gaze assessment session
Primary outcome [2] 333960 0
Assessment of saccades using the commercial eye tracker (GP3-HD, Gazepoint Canada).
Timepoint [2] 333960 0
Assessed after single eye gaze assessment session
Secondary outcome [1] 418280 0
Nil
Timepoint [1] 418280 0
Nil

Eligibility
Key inclusion criteria
1.People diagnosed with diagnosed Glaucoma.
2.Age matched healthy controls
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Glaucoma - no other neuro-optic disease or neurodegenerative disease
Healthy age-matched controls - no diagnosed neuro-optic disease

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
8/05/2023
Actual
Date of last participant enrolment
Anticipated
9/05/2023
Actual
Date of last data collection
Anticipated
9/05/2025
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39538 0
3001 - Melbourne
Recruitment postcode(s) [2] 39536 0
3040 - Essendon

Funding & Sponsors
Funding source category [1] 313150 0
University
Name [1] 313150 0
RMIT University
Country [1] 313150 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
GPO Box 2476, Melbourne VIC 3001 Australia
Country
Australia
Secondary sponsor category [1] 314852 0
None
Name [1] 314852 0
Address [1] 314852 0
Country [1] 314852 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312390 0
RMIT Human Research Ethics Committee
Ethics committee address [1] 312390 0
GPO Box 2476, Melbourne VIC 3001 Australia
Ethics committee country [1] 312390 0
Australia
Date submitted for ethics approval [1] 312390 0
04/04/2023
Approval date [1] 312390 0
Ethics approval number [1] 312390 0

Summary
Brief summary
Glaucoma results in irreversible visual field loss so early detection and diagnosis of this disease is needed to avoid sight loss. Pupillary light responses and analysis of saccadic movements are new techniques for the detection of glaucoma. The purpose of this study is to identify robust features of pupillary light responses and saccades as demonstrated using a commercial eye tracking device that may be used to identify and assess for abnormalities of eye gaze. The ultimate aim of this work is to develop an automated diagnostic tool for the diagnosis and assessment of abnormalities for people living in rural and remote communities. Patients will be able to record eye gaze under specified conditions. The recordings will be analysed and eye gaze recordings and their analysis sent to a specialist physician.
The aim of this study is to ascertain features of eye gaze that are most useful in identifying differences between glaucoma patients and healthy age-matched controls using a commercially available eye tracker. The hypothesis is that Glaucoma patients will exhibit significantly different eye gaze responses compared with healthy age-matched controls.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124494 0
Prof Dinesh Kumar
Address 124494 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124494 0
Australia
Phone 124494 0
+61 399251954
Fax 124494 0
Email 124494 0
dinesh.kumar@rmit.edu.au
Contact person for public queries
Name 124495 0
Prof Dinesh Kumar
Address 124495 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124495 0
Australia
Phone 124495 0
+61 399251954
Fax 124495 0
Email 124495 0
dinesh.kumar@rmit.edu.au
Contact person for scientific queries
Name 124496 0
Prof Dinesh Kumar
Address 124496 0
RMIT University
GPO Box 2476, Melbourne VIC 3001 Australia
Country 124496 0
Australia
Phone 124496 0
+61 399251954
Fax 124496 0
Email 124496 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 Glaucoma)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18345Study protocol    Directly from researchers conducting the study
18346Informed consent form    Directly from researchers conducting the study
18347Ethical 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.