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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12618001938291
Ethics application status
Approved
Date submitted
25/10/2018
Date registered
29/11/2018
Date last updated
13/11/2019
Date data sharing statement initially provided
29/11/2018
Date results information initially provided
13/11/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Objectively Testing Visual Performance in Young Children
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Scientific title
Phase II of Objective Assessment of Visual Performance Using Optokinetic Nystagmus in Young Children
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Secondary ID [1]
296340
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Nil
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Universal Trial Number (UTN)
U1111-1222-3737
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Vision Impairment
310064
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Condition category
Condition code
Eye
308820
308820
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0
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Normal eye development and function
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
313037
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Not applicable
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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.)
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Control group
Active
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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Timepoint [1]
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The children will be shown trials intermittently for up to 5 minutes assessment.
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Secondary outcome [1]
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Nil
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Assessment method [1]
352939
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Timepoint [1]
352939
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Nil
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Eligibility
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))
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Minimum age
3
Years
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Maximum age
5
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose
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Duration
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Selection
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Timing
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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
YES NO
YES TP FP
New hardware
NO FN TN
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
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
19/11/2018
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Date of last participant enrolment
Anticipated
1/02/2019
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Actual
11/03/2019
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Date of last data collection
Anticipated
8/02/2019
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Actual
11/03/2019
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Sample size
Target
20
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Accrual to date
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Final
20
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
300943
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Commercial sector/Industry
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Name [1]
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Objective Acuity (Australia) Pty Ltd
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Address [1]
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C/- JT&P Pty Ltd, Level 10, 446 Collins Street, Melbourne, VIC 3000, Australia
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Country [1]
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Objective Acuity (Australia) Pty Ltd
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Address
C/- JT&P Pty Ltd, Level 10, 446 Collins Street, Melbourne, VIC 3000, Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
300515
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Address [1]
300515
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Country [1]
300515
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301709
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HESC (Human Ethics Sub Committee) Psychology Health and Applied Sciences
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Ethics committee address [1]
301709
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The University of Melbourne
Grattan Street,
Parkville, Victoria, 3010
The University of Melbourne
Victoria 3010
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Ethics committee country [1]
301709
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Australia
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Date submitted for ethics approval [1]
301709
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03/10/2018
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Approval date [1]
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02/11/2018
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Ethics approval number [1]
301709
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Christine Nearchou
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Address
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The University of Melbourne
Parkville VIC 3010, Australia
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Country
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Australia
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Phone
87842
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+61 390359899
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Adam Podmore
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Address
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Objective Acuity Ltd
Level 10, 2 Kitchener Street, Auckland, New Zealand
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Country
87843
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New Zealand
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Phone
87843
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+6421382326
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Fax
87843
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Email
87843
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[email protected]
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Contact person for scientific queries
Name
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Dr Christine Nearchou
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Address
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The University of Melbourne
Parkville VIC 3010, Australia
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Country
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Australia
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Phone
87844
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+61 390359899
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Fax
87844
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Email
87844
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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