Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001100987
Ethics application status
Approved
Date submitted
19/08/2020
Date registered
22/10/2020
Date last updated
6/04/2022
Date data sharing statement initially provided
22/10/2020
Date results provided
6/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reliability Of Oculomotor Tests Used To Assess Mild Traumatic Brain Injury (mTBI)
Scientific title
Reliability Of Oculomotor Tests Used To Assess mTBI in healthy adults
Secondary ID [1] 302070 0
None
Universal Trial Number (UTN)
U1111-1233-0051
Trial acronym
ROMT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oculomotor dysfunction 318668 0
Mild traumatic brain injury 318669 0
Condition category
Condition code
Neurological 316687 316687 0 0
Other neurological disorders
Injuries and Accidents 317043 317043 0 0
Other injuries and accidents
Eye 317044 317044 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
Computerised eye tracking tests that consist of ~10-15minutes of different tests. The tests centre around watching a target presented on a computer screen. Tests include fixation, pursuits, ocular following, vestibulo-ocular test, saccades and the Stroop test. The participants will do the tests once (the tests are presented in a random order), wait at least 5 minutes and then repeat the eye tests again (also in a random order)
Intervention code [1] 318368 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324814 0
This a composite primary outcome (Oculomotor outcomes, including saccades, anti-saccades, fixations, smooth pursuits, ocular following, Vestibulo-ocular reflex, Stroop test and egocentric localisation) . All outcomes are determined from computerised eye tracking record record by an infra-red camera.
Timepoint [1] 324814 0
during one-off eye-tracking session where the participant performs all tests twice
Secondary outcome [1] 385836 0
Nil
Timepoint [1] 385836 0
Nil

Eligibility
Key inclusion criteria
Adults over the age of 18 years that have normal (or corrected to normal) vision and no visual issues that affect eye movements (such as; ADHD, loss of vision in one eye, stroke or cranial nerve palsy).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non other than what is specified in the inclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Twenty-five adults will be recruited A sample size of 25 was selected based on an expected intraclass correlation coefficient of 0.8 and a 95% confidence interval that excluded 0.61, which was predefined as the lowest acceptable level of test-retest reliability based on the recommendations made by Shrout (1998) (Barch & Yarkoni, 2013; Koo & Li, 2016; Shrout, 1998; Walter, Eliasziw, & Donner, 1998). All adults over the age of 18 would be eligible to participate, but an attempt was made to recruit young adults where possible. A convenience sampling frame was used.

To assess test-retest reliability of the primary outcome measures intraclass correlation coefficients will be calculated using two way mixed models with consistency as the type and single measurements. Spearman’s correlation coefficients will also be calculated to account for the non-parametric nature of some of the data. Scatter plots will also be created to visually assess the data. Bland-Altman plots will also be presented as an alternative measure of validity.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/07/2020
Date of last participant enrolment
Anticipated
Actual
1/10/2021
Date of last data collection
Anticipated
30/11/2020
Actual
31/10/2021
Sample size
Target
35
Accrual to date
Final
35
Recruitment outside Australia
Country [1] 22861 0
New Zealand
State/province [1] 22861 0
Auckand

Funding & Sponsors
Funding source category [1] 305476 0
University
Name [1] 305476 0
University of Auckland
Country [1] 305476 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 305874 0
Other
Name [1] 305874 0
New Zealand College of Chiropractic
Address [1] 305874 0
6 Harrison Road, Mt Wellington 1060 Auckland
Country [1] 305874 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305792 0
Health and Disabilities Ethics Committee New Zealand
Ethics committee address [1] 305792 0
Ethics committee country [1] 305792 0
New Zealand
Date submitted for ethics approval [1] 305792 0
21/05/2019
Approval date [1] 305792 0
21/08/2019
Ethics approval number [1] 305792 0
19/CEN/130

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

Contacts
Principal investigator
Name 101610 0
Dr Phil Turnbull
Address 101610 0
University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 101610 0
New Zealand
Phone 101610 0
+64 9 373 7599
Fax 101610 0
Email 101610 0
[email protected]
Contact person for public queries
Name 101611 0
Alice Cade
Address 101611 0
University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 101611 0
New Zealand
Phone 101611 0
+64 21 400 739
Fax 101611 0
Email 101611 0
[email protected]
Contact person for scientific queries
Name 101612 0
Alice Cade
Address 101612 0
University of Auckland, School of Optometry and Vision Science, 85 Park Road, Grafton, Auckland 1023
Country 101612 0
New Zealand
Phone 101612 0
+64 21 400 739
Fax 101612 0
Email 101612 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Public

Conditions for requesting access:
• -

What individual participant data might be shared?
• Analytical code (R language) which is used to analyse the raw files of eye tracking data that can be recorded during the eye tracking tests

What types of analyses could be done with individual participant data?
• Reproducing results in similar studies

When can requests for individual participant data be made (start and end dates)?
From:
Starts date

To:
some code is available now (16/09/2020)
End date - code will be available in perpetuity

Where can requests to access individual participant data be made, or data be obtained directly?
• By contacting the principal investigator: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
Documents were uploaded by study researchers but have since been removed.

Documents added automatically
No additional documents have been identified.