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Trial registered on ANZCTR


Registration number
ACTRN12617000338369
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
3/03/2017
Date last updated
8/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using eye movements to measure vision in children
Scientific title
Objective Assessment of Visual Performance Using Optokinetic Nystagmus in Young Children
Secondary ID [1] 290610 0
None
Universal Trial Number (UTN)
U1111-1190-2839
Trial acronym
OKN (optokinetic nystagmus) study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amblyopia 301102 0
Anisometropia 301103 0
Significant refractive error 301104 0
Visual impairment 301105 0
Strabismus 301106 0
Condition category
Condition code
Eye 300873 300873 0 0
Normal eye development and function
Eye 300874 300874 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a clinical device designed by Dr. Jason Turuwhenua, and consists of multiple components: a stimulus display unit, infrared (IR) camera for optokinetic nystagmus (OKN) video recording, IR illumination, and a computer. Data collection will be done with a prototype device by Objective Acuity Ltd, a UniServices (University of Auckland) start-up company co-founded by Lead investigator, Dr. Jason Turuwhenua, and A/Prof. Ben Thompson. The overall aim of this study is to accurately test visual acuity in young children to allow for the early detection and treatment of vision problems. The OKN device assesses visual acuity by inducing and measuring an involuntary, reflexive eye movement known as OKN. This eye movement only occurs when a moving target is visible. The intervention will be done one eye at a time, and the eye not being tested is covered by an eye patch.

The intervention will be delivered by optometrist(s), orthoptist(s), ophthalmologist(s), and vision researcher(s) with minimum 2 years' clinical/clinical research experience. The mode of delivery is face to face, one participant at a time, in an optometry/ophthalmology clinic or a clinic in vision research institution..

Children will undergo the intervention once, but in the event of technical difficulties or child unable to cooperate, we will invite children and their parents to reschedule for a second attempt. The duration of intervention is approximately 10 minutes (5 minutes per eye).
Intervention code [1] 297337 0
Early detection / Screening
Comparator / control treatment
The sensitivity and specificity of the OKN device will be compared against the clinical gold-standard crowded HOTV visual acuity test using the EVA (electronic visual acuity) system. Children will be shown letters on the EVA monitor one eye at a time, and asked to identify the letter verbally or by letter-matching. The eye not being tested is covered by an eye patch. All children enrolled in this trial will have their visual acuity measured using both the gold-standard and OKN device.
Control group
Active

Outcomes
Primary outcome [1] 300302 0
To assess the sensitivity and specificity of the OKN device for detecting uncorrected monocular visual acuity impairment caused by strabismic amblyopia, anisometropic amblyopia or refractive error in developmentally normal children from 3-6-years of age. The HOTV test delivered using the Electronic Visual Acuity (EVA) system will be used as the gold-standard comparison.

Uncorrected monocular visual acuity impairment will be defined using the ATS-HOTV test in the absence of refractive correction according to age-specific visual acuity cutoffs for vision screening provided by the American Association for Pediatric Ophthalmology and Strabismus (AAPOS, 2014): 36-47 months, >0.4 LogMAR; 49-59 months, >0.3 LogMAR; 60-83 months, >0.2 LogMAR.
Timepoint [1] 300302 0
Data analysis will be conducted between March 19th to 31st 2018.
Secondary outcome [1] 329655 0
Testability of the OKN device (proportion of completed measurements vs. attempts) compared to the ATS-HOTV test. A complete measurement is defined as a visual acuity measurement at the age-appropriate cut-off LogMAR level for each eye separately.
Timepoint [1] 329655 0
The proposed timepoint for calculation and presentation of secondary outcome is January-March 2018.
Secondary outcome [2] 329656 0
To assess the specificity and sensitivity of OKN in the detection of impaired visual acuity for pre-specified subgroups, if sufficient number of children can be recruited for each category:
* Study sites (Auckland vs Melbourne vs Texas)
* Age groups (36-47, 48-59, 60-83 months of age)
* Sex (Male, Female)
* Hyperopes vs. Myopes
* High astigmatism vs. low/no astigmatism
* Strabismic vs. non-strabismic
Timepoint [2] 329656 0
The proposed timepoint for calculation and presentation of secondary outcome is January-March 2018.

Eligibility
Key inclusion criteria
* Aged 3-6 years old (36-83 months at the time of registration)
* Have parent(s)/guardian(s) willing to provide informed consent
* Had paediatric eye examination, including cycloplegic refraction within the past 6 months OR is a child for whom the parent consents to having a paediatric eye examination including cycloplegic refraction at the time of registration.
Minimum age
36 Months
Maximum age
83 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Infantile nystagmus syndrome
* Eye muscle surgery within the past 6 months
* Current eye disease
* Developmental delay (known or suspected)
* Systemic disease or syndrome

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analysis will be performed using SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) and R version 3.3 (R Foundation for Statistical Computing). All statistical tests will be two-sided at 5% significance level. The STROBE statement will be used as the guidelines for reporting observational studies.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2017
Actual
3/03/2017
Date of last participant enrolment
Anticipated
9/03/2018
Actual
Date of last data collection
Anticipated
9/03/2018
Actual
Sample size
Target
120
Accrual to date
71
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15480 0
3010 - University Of Melbourne
Recruitment outside Australia
Country [1] 8415 0
New Zealand
State/province [1] 8415 0
Auckland
Country [2] 8416 0
United States of America
State/province [2] 8416 0
Texas

Funding & Sponsors
Funding source category [1] 295056 0
Government body
Name [1] 295056 0
Ministry of Business, Innovation and Employment
Country [1] 295056 0
New Zealand
Funding source category [2] 298621 0
Commercial sector/Industry
Name [2] 298621 0
Objective Acuity Ltd (University of Auckland UniServices company)
Country [2] 298621 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Auckland Bioengineering Institute
70 Symonds Street
Auckland 1010
AND
School of Optometry & Vision Science
85 Park Road
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 293870 0
None
Name [1] 293870 0
Address [1] 293870 0
Country [1] 293870 0
Other collaborator category [1] 279322 0
Individual
Name [1] 279322 0
Dr. Shuan Dai (Eye Doctors)
Address [1] 279322 0
Eye Doctors Ltd
Level 2, 90 Greenlane Rd East
Auckland, 1050
Country [1] 279322 0
New Zealand
Other collaborator category [2] 279323 0
Individual
Name [2] 279323 0
Prof. Eileen Birch (Retina Foundation of the Southwest)
Address [2] 279323 0
Retina Foundation of the Southwest
9600 N Central Expy #200, Dallas, TX 75231
Country [2] 279323 0
United States of America
Other collaborator category [3] 279407 0
Individual
Name [3] 279407 0
Ms Christine Nearchou (University of Melbourne Eye Care Clinic)
Address [3] 279407 0
University of Melbourne Eye Care Clinic
2/800 Swanston St
University of Melbourne
VIC 3010
Country [3] 279407 0
Australia
Other collaborator category [4] 279931 0
University
Name [4] 279931 0
A/Prof. Ben Thompson (University of Waterloo)
Address [4] 279931 0
School of Optometry and Vision Science
University of Waterloo
200 University Avenue West
Waterloo, Ontario, Canada
N2L 3G1
Country [4] 279931 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296402 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 296402 0
Ethics committee country [1] 296402 0
New Zealand
Date submitted for ethics approval [1] 296402 0
08/11/2016
Approval date [1] 296402 0
04/01/2017
Ethics approval number [1] 296402 0
018420

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1354 1354 0 0
/AnzctrAttachments/371914-Outcome Approved with comment.pdf (Ethics approval)
Attachments [2] 1355 1355 0 0
/AnzctrAttachments/371914-OKN protocol.pdf (Protocol)
Attachments [3] 1541 1541 0 0
/AnzctrAttachments/371914-child_PIS CF_018420_ANZCTR.pdf (Participant information/consent)
Attachments [4] 2417 2417 0 0
/AnzctrAttachments/371914-OKN protocol_version14thNovember2017_LC.pdf (Protocol)

Contacts
Principal investigator
Name 70714 0
Dr Jason Turuwhenua
Address 70714 0
Auckland Bioengineering Institute
The University of Auckland
Private Bag 92019
Auckland 1142
Country 70714 0
New Zealand
Phone 70714 0
+64 9 923 5807
Fax 70714 0
Email 70714 0
j.turuwhenua@auckland.ac.nz
Contact person for public queries
Name 70715 0
Lily Yu-Li Chang
Address 70715 0
Auckland Bioengineering Institute
The University of Auckland
Private Bag 92019
Auckland 1142
Country 70715 0
New Zealand
Phone 70715 0
+64 9 923 1689
Fax 70715 0
Email 70715 0
lily.chang@auckland.ac.nz
Contact person for scientific queries
Name 70716 0
Jason Turuwhenua
Address 70716 0
Auckland Bioengineering Institute
The University of Auckland
Private Bag 92019
Auckland 1142
Country 70716 0
New Zealand
Phone 70716 0
+64 9 923 5807
Fax 70716 0
Email 70716 0
j.turuwhenua@auckland.ac.nz

No information has been provided regarding IPD availability


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.