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
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
Nil
Universal Trial Number (UTN)
U1111-1222-3737
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

Intervention/exposure
Study type
Observational
Patient registry
False
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
Active

Outcomes
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
Nil
Timepoint [1] 352939 0
Nil

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))
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Purpose
Duration
Selection
Timing
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/11/2018
Date of last participant enrolment
Anticipated
1/02/2019
Actual
11/03/2019
Date of last data collection
Anticipated
8/02/2019
Actual
11/03/2019
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300943 0
Commercial sector/Industry
Name [1] 300943 0
Objective Acuity (Australia) Pty Ltd
Country [1] 300943 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Objective Acuity (Australia) Pty Ltd
Address
C/- JT&P Pty Ltd, Level 10, 446 Collins Street, Melbourne, VIC 3000, Australia
Country
Australia
Secondary sponsor category [1] 300515 0
None
Name [1] 300515 0
Address [1] 300515 0
Country [1] 300515 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301709 0
HESC (Human Ethics Sub Committee) Psychology Health and Applied Sciences
Ethics committee address [1] 301709 0
Ethics committee country [1] 301709 0
Australia
Date submitted for ethics approval [1] 301709 0
03/10/2018
Approval date [1] 301709 0
02/11/2018
Ethics approval number [1] 301709 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87842 0
Dr Christine Nearchou
Address 87842 0
The University of Melbourne
Parkville VIC 3010, Australia
Country 87842 0
Australia
Phone 87842 0
+61 390359899
Fax 87842 0
Email 87842 0
nearchou@unimelb.edu.au
Contact person for public queries
Name 87843 0
Adam Podmore
Address 87843 0
Objective Acuity Ltd
Level 10, 2 Kitchener Street, Auckland, New Zealand
Country 87843 0
New Zealand
Phone 87843 0
+6421382326
Fax 87843 0
Email 87843 0
a.podmore@objectiveacuity.com
Contact person for scientific queries
Name 87844 0
Christine Nearchou
Address 87844 0
The University of Melbourne
Parkville VIC 3010, Australia
Country 87844 0
Australia
Phone 87844 0
+61 390359899
Fax 87844 0
Email 87844 0
nearchou@unimelb.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


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.