Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000298617p
Ethics application status
Not yet submitted
Date submitted
26/01/2023
Date registered
17/03/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
17/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of smartphone screen surround colour on childhood myopia progression
Scientific title
Effect of smartphone screen surround colour on childhood myopia progression
Secondary ID [1] 308641 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 328554 0
Condition category
Condition code
Eye 325570 325570 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are given the same model of android smartphone to use for two years. The smartphone operates normally but has a built-in app that runs in the background that displays coloured light stimuli consisting of a coloured border at the edge of the screen whenever the screen is on and a 200 msec full-screen coloured flash (same colour as the border) when the screen is initially turned on.

The surrounds (and flashes) will be switched off from 6 pm until 6 am the next day to avoid disruption to participants’ circadian rhythm.

For the first year, participants will be allocated into two groups by permuted block randomisation, stratified by gender, to receive either blue-coloured stimuli or red-coloured stimuli on the phone. After the outcome measures at 9 months, an analysis will be conducted to determine which colour (red or blue) is most effective at slowing myopia progression. This will determine the allocations made at the beginning of the second year of the study.

For the second year, participants who received the most effective coloured stimuli in the first year (as determined by a 9-month analysis) will switch to receiving white-coloured stimuli for the second year. Participants who received the least effective coloured stimuli in the first year will switch to receiving the most effective coloured stimuli for the second year.

An example of different coloured stimuli that would be displayed is as follows.

Group 1 (20 participants, male & female): Red (1st year)-9 months measure-Blue or White (2nd year)
Group 2 (20 participants, male & female): Blue (1st year)-9 months measure-Red or White (2nd year)
Intervention code [1] 325257 0
Treatment: Other
Intervention code [2] 325315 0
Treatment: Devices
Comparator / control treatment
Modified crossover design.
Control group
Active

Outcomes
Primary outcome [1] 333620 0
Axial length for each eye over two years compared to baseline using partial coherence interferometry (Lenstar 900; Haag-Streit, Switzerland).
Timepoint [1] 333620 0
Baseline, 9 months , 12 months (primary endpoint), 18 months and 24 months after enrolment.
Primary outcome [2] 333623 0
Cycloplegic refraction for each eye over two years compared to baseline. Cycloplegic refraction will be conducted 30 minutes after administration of two drops of 1% tropicamide for each eye using an autorefractor with an average of five measures each eye.
Timepoint [2] 333623 0
Baseline, 9 months, 12 months (primary endpoint), 18 months and 24 months after enrolment.
Secondary outcome [1] 417780 0
Choroidal thickness for each eye over two years compared to baseline using optical coherence tomography (OCT). The thickness will be obtained from OCT images using automated software.
Timepoint [1] 417780 0
Baseline, 9 months, 12 months, 18 months and 24 months after enrolment.

Eligibility
Key inclusion criteria
• Are between 9 to 11 years of age.
• Have a visual acuity of 6/6 each eye with their habitual correction.
• Have a refractive error of -1.00D to -3.00D spherical equivalent.
• Have astigmatism equal or less than -1.50D
• Have anisometropia less than or equal to -1.00D.
• Have normal colour vision.
Minimum age
9 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have any known systemic abnormalities that might affect visual functions or refractive development.
• Have ocular pathology, amblyopia, ocular injury and surgery or other ocular anomalies.
• On medication that might affect visual function or development.
• Have prior or ongoing myopia control treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
This project relies on a complex smartphone app, and the supplier was not able to supply it within the agreed timeframe.
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 25221 0
New Zealand
State/province [1] 25221 0
Auckland

Funding & Sponsors
Funding source category [1] 312664 0
University
Name [1] 312664 0
The University of Auckland
Country [1] 312664 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
School of Optometry and Vision Science, The University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand 1023
Country
New Zealand
Secondary sponsor category [1] 314712 0
None
Name [1] 314712 0
Address [1] 314712 0
Country [1] 314712 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311969 0
Health and Disability Ethics Committees (HDECs)
Ethics committee address [1] 311969 0
Ethics committee country [1] 311969 0
New Zealand
Date submitted for ethics approval [1] 311969 0
14/04/2023
Approval date [1] 311969 0
Ethics approval number [1] 311969 0

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

Contacts
Principal investigator
Name 123006 0
Dr John Phillips
Address 123006 0
School of Optometry and Vision Science, The University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand 1023
Country 123006 0
New Zealand
Phone 123006 0
+64 9 923 6703
Fax 123006 0
Email 123006 0
[email protected]
Contact person for public queries
Name 123007 0
John Phillips
Address 123007 0
School of Optometry and Vision Science, The University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand 1023
Country 123007 0
New Zealand
Phone 123007 0
+64 9 923 6703
Fax 123007 0
Email 123007 0
[email protected]
Contact person for scientific queries
Name 123008 0
John Phillips
Address 123008 0
School of Optometry and Vision Science, The University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand 1023
Country 123008 0
New Zealand
Phone 123008 0
+64 9 923 6703
Fax 123008 0
Email 123008 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data involves children


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.