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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Objectively Testing Visual Performance in Young Children
Scientific title
Phase II of Objective Assessment of Visual Performance Using Optokinetic Nystagmus in Young Children
Secondary ID [1] 296340 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision Impairment 310064 0
Condition category
Condition code
Eye 308820 308820 0 0
Normal eye development and function

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The child will look at a pattern displayed on a display screen from 1.5M. The Objective Acuity system will track the eye movements to determine whether they have Optokinetic Nystagmus (OKN), when looking at the screen. The study will be carried out by Dr. Christine Nearchou at The University of Melbourne, School of Optometry.

The clinical device (otherwise referred to as the OKN device) is a system designed by Objective Acuity Ltd, which consists of a computer, stimulus display unit, an IR video camera, eye tracking system and background IR illumination.

Stimulus display unit - dynamic stimulus pattern designed to induce OKN are presented on a 27” inch monitor.

IR video camera – videos of participant’s eyes and face are recorded for OKN analysis. The camera lens is positioned at the plane of the monitor, and the lens was set to capture the region of the face. Camera resolution was set to 640 × 480 pixels, at 30 Hz refresh rate. Appropriate IR lighting is used to provide optimal illumination of the participant’s eyes to aid image analysis.

The recording of the video is synchronized to the presentation of the stimulus on the monitor using Matlab in the master computer.

The participant testing will be up to 5 minutes. There will be no follow up assessment.

The collection of the data (eye signal and video footage) as input into the new system and old system analysis will be simultaneously collected.

Intervention code [1] 313037 0
Not applicable
Comparator / control treatment
The OKN device will collect the signal from the eye movements and video footage of the eye movements. The new system analysis will only use the eye signals to provide the result. Whereas the comparator will use software to analysis the video footage (otherwise referred to as the old system.)
Control group

Primary outcome [1] 307794 0
Detection of OKN signal by the Objective Acuity device compared with the old system OKN detection (OKN signal from videos from previous Objective Acuity system)
Timepoint [1] 307794 0
The children will be shown trials intermittently for up to 5 minutes assessment.
Secondary outcome [1] 352939 0
Timepoint [1] 352939 0

Key inclusion criteria
Children will be eligible for inclusion if they meet the following criteria:
• Aged 3-5 years old (36-71 months at the time of registration)
• Have parent(s)/guardian(s) willing to provide informed consent
• Have no known visual impairment (VA < 6/24 or LogMar 0.6))
Minimum age
3 Years
Maximum age
5 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Potentially eligible children will be excluded if they have any of the criteria below:
• Infantile nystagmus syndrome
• Eye muscle surgery within the past 6 months
• Current eye disease
• Developmental delay (known or suspected)
• Systemic disease or syndrome
• Visual impairment <6/24 or LogMar 0.6

Study design
Statistical methods / analysis
20 children at study site in Melbourne will be recruited and included in any statistical analysis.

Data analysis:

1- For eye movement signals we will compute the Pearson's correlation coefficients and the p-values using a Student's t distribution for a transformation of the correlation.

2- For OKN detection analysis we will calculate sensitivity and specificity using:
video from the old already validated system
New Test = The new eye tracking system

TP = OKN is detected by both systems
FP = OKN is NOT detected by the old system, but it is detected by the new system
FN = OKN is detected by the old system, but it is NOT detected by the new system
TN = OKN is NOT detected by either the old system nor the new system

Old system
New hardware

Sensitivity = TP/(TP + FN)
Specificity = TN/(TN + FP)
Positive predictive value = TP / (TP + FP)
Negative predictive value = TN / (FN + TN)
Statistical analysis will be performed by Objective Acuity using Matlab

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 300943 0
Commercial sector/Industry
Name [1] 300943 0
Objective Acuity (Australia) Pty Ltd
Address [1] 300943 0
C/- JT&P Pty Ltd, Level 10, 446 Collins Street, Melbourne, VIC 3000, Australia
Country [1] 300943 0
Primary sponsor type
Commercial sector/Industry
Objective Acuity (Australia) Pty Ltd
C/- JT&P Pty Ltd, Level 10, 446 Collins Street, Melbourne, VIC 3000, Australia
Secondary sponsor category [1] 300515 0
Name [1] 300515 0
Address [1] 300515 0
Country [1] 300515 0

Ethics approval
Ethics application status
Ethics committee name [1] 301709 0
HESC (Human Ethics Sub Committee) Psychology Health and Applied Sciences
Ethics committee address [1] 301709 0
The University of Melbourne
Grattan Street,
Parkville, Victoria, 3010

The University of Melbourne
Victoria 3010
Ethics committee country [1] 301709 0
Date submitted for ethics approval [1] 301709 0
Approval date [1] 301709 0
Ethics approval number [1] 301709 0

Brief summary
The study will test whether a device can detect OKN in children. The purpose of this study is that it is important in the development of a device that can detect vision problems in children.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 87842 0
Dr Christine Nearchou
Address 87842 0
The University of Melbourne
Parkville VIC 3010, Australia
Country 87842 0
Phone 87842 0
+61 390359899
Fax 87842 0
Email 87842 0
Contact person for public queries
Name 87843 0
Mr Adam Podmore
Address 87843 0
Objective Acuity Ltd
Level 10, 2 Kitchener Street, Auckland, New Zealand
Country 87843 0
New Zealand
Phone 87843 0
Fax 87843 0
Email 87843 0
Contact person for scientific queries
Name 87844 0
Dr Christine Nearchou
Address 87844 0
The University of Melbourne
Parkville VIC 3010, Australia
Country 87844 0
Phone 87844 0
+61 390359899
Fax 87844 0
Email 87844 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary