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Trial registered on ANZCTR


Registration number
ACTRN12620000061932
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
24/01/2020
Date last updated
24/01/2020
Date data sharing statement initially provided
24/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of standard versus customised spectacle treatment for children with asymmetric refractive error
Scientific title
Measuring aniseikonia: investigating neuroplasticity and image factors in amblyopic children using aniseikonia-correcting spectacles (MAGNIFY) study
Secondary ID [1] 300106 0
None
Universal Trial Number (UTN)
Trial acronym
MAGNIFY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anisometropia 315635 0
Aniseikonia 315636 0
Amblyopia 315849 0
Condition category
Condition code
Eye 313930 313930 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be provided with aniseikonia-correcting lenses to be worn for the optical treatment of their anisometropic amblyopia. These spectacle lenses are designed to equalise focus and also reduce aniseikonia (image size differences) between the two eyes. Correction will be administered by clinically qualified and registered orthoptists and optometrists who are named study investigators. Participants will be required to wear their allocated glasses full time (at least 75% of waking hours) for 15 weeks. Compliance with glasses wear will be monitored through a daily glasses wear dairy that will take less than 5mins to complete each day (for the parent). No other vision therapy will be administered during the intervention period.
Intervention code [1] 316385 0
Treatment: Devices
Comparator / control treatment
A Standard spectacle lenses will be a single vision lens which corrects image focus only by correcting any hypermetropia or myopia and any associated astigmatism. This standard spectacle lens would be what they would normally receive during standard clinical treatment
Control group
Active

Outcomes
Primary outcome [1] 322323 0
Change in best-corrected distance visual acuity in the amblyopic eye from baseline (dispensing visit) to 15 weeks post-randomisation, measured using the highly standardised HOTV protocol EVA testing system
Timepoint [1] 322323 0
From baseline (Dispensing visit) to 15 weeks post-randomisation
Secondary outcome [1] 378080 0
Change from baseline (dispensing visit) in best-corrected distance visual acuity in the amblyopic eye, fellow eye and both eyes at 5, 10 and 15 weeks analysed post-randomisation as a composite score measured using the highly standardised HOTV protocol EVA testing system
Timepoint [1] 378080 0
From baseline to 5, 10 and 15 weeks post-randomisation
Secondary outcome [2] 378081 0
Change from baseline in stereopsis at 5, 10 and 15 weeks post-randomisation measured using Randot Preschool Stereotest
Timepoint [2] 378081 0
Baseline measurements from dispensing visit and 5, 10 and 15 weeks after randomization to standard lenses group or aniseikonia correcting lenses group.
Secondary outcome [3] 378082 0
Spectacle wear compliance will be based on the total time the participants wore their glasses as recorded in the participants daily wear diary. A participant is considered compliant if they have worn their glasses for equal to or greater than 75% of their awake time
Timepoint [3] 378082 0
At follow up visits 5, 10 and 15 weeks after randomization
Secondary outcome [4] 378083 0
Change in quality of life using the PedEyeQ Quality of life questionnaire.
Timepoint [4] 378083 0
Baseline measurement (Dispensing visit) and 15 weeks post randomization to standard lenses or aniseikonia correcting lenses group.
Secondary outcome [5] 378084 0
Serious adverse events such as eye strain or headaches, reported by the participants or identified via eye exams during follow-up visits.
Timepoint [5] 378084 0
5, 10 and 15 weeks after randomization.

Eligibility
Key inclusion criteria
• 4-8 Years of age
• Anisometropia equal to or greater than 1.50 DS difference in spherical equivalent between eyes
• Uncorrected Vision in the worst eye of 6/12 (0.30 logMAR) or worse with an interocular difference of 2 lines or more. Visual acuity will be measured using the ATS-HOTV protocol on the Electronic Visual Acuity tester (EVA).
• No manifest strabismus at near or distance on cover test
• Refractive corrections meet the following criteria and are based on a cycloplegic refraction that is not more than six months old. The criteria are: 1) Hyperopia: not be under-corrected by more than +1.50D spherical equivalent and the reduction in plus sphere must be identical between the two eyes. 2) Anisometropia: full correction of the anisometropic difference. 3) Astigmatism: full cylindrical power will be prescribed. 4) Cylinder axis in the spectacle lenses in both eyes must be equal to or less than +/-6 degrees of the axis of the cycloplegic refraction when cylinder power is equal to or greater than 1.00 D.
• Willing and being able to provide written informed consent for participation in the study
Minimum age
4 Years
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of a constant or alternating strabismus at any distance, previous amblyopia treatment, Myopia > 6.00D, previous intraocular surgery, any co-existent ocular pathology and any known neurological conditions. Not willing to wear spectacle refractive correction

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)
Allocation concealment: Participants will be randomized to the standard lenses or aniseikonia-correcting lenses group after they are consented to take part and confirmed to be eligible for the trial. Randomization will be conducted using an envelope or computer-based system. Allocation to each group will be made using a 1:1 ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A sample size of 50 patients (25 per arm) will provide 95% power at p=0.05 to detect a minimal clinically important difference of 0.20 logMAR units improvement in visual acuity at 15 weeks, assuming a standard deviation of 0.17. This sample size allows for an overall loss-to-follow-up of 15%.
All statistical analyses will be performed using SAS version 9.4. All statistical tests will be two-tailed and at 5% significance level throughout the analyses and all treatment evaluations will be performed on the principle of ‘intention to treat’ unless otherwise specified. Per protocol analysis will be conducted for the primary outcome as sensitivity analysis. No adjustments for multiple comparisons are planned for any of the outcomes. No imputation will be performed for missing data.
All results will be presented overall and by treatment groups. Summaries of continuous variables which are normally distributed will be presented as means and standard deviations or medians and inter-quartiles for skewed data, while categorical variables will be presented as frequencies and percentages.
For visual acuity smaller or more negative values mean better vision. For this study change from baseline (0 week) to follow-up in distance visual acuity of the amblyopic eye will be calculated as (Baseline – Follow-up). Positive change from baseline values indicate there is improvement, and negative values indicates worsening of the condition.
When the method of mixed model for repeated measure, MMRM, is used, the model will include treatment, time, treatment by time interaction, baseline value as fixed effects, and subject as random effect, unless otherwise stated. The within-subject errors will be modelled using an appropriate covariance matrix. Candidate structures include but are not restricted to unstructured, autoregressive, Toeplitz, compound symmetry and spatial. Kenward-Roger method will be used to estimate the denominator degrees of freedom for fixed effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22187 0
New Zealand
State/province [1] 22187 0
Auckland

Funding & Sponsors
Funding source category [1] 304550 0
Government body
Name [1] 304550 0
Health Research Council of New Zealand
Address [1] 304550 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1141
Country [1] 304550 0
New Zealand
Primary sponsor type
University
Name
The University Of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 304828 0
None
Name [1] 304828 0
Address [1] 304828 0
Country [1] 304828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304977 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 304977 0
Private Bag 92019
Auckland
1142
Ethics committee country [1] 304977 0
New Zealand
Date submitted for ethics approval [1] 304977 0
06/08/2019
Approval date [1] 304977 0
11/10/2019
Ethics approval number [1] 304977 0
023628

Summary
Brief summary
Amblyopia, also known as lazy eye, is a developmental disorder of vision whereby the brain ignores the information from one eye. This leads to a reduction in the vision of that eye. Also, the two eyes fail to work together resulting in a lack of binocular vision. Anisometropia is a significant difference in focusing between the two eyes caused by underlying anatomical factors. Significant anisometropia limits binocular co-operation and is a well known cause of amblyopia either alone or in combination with a strabismus /misalignment of one eye. The defocus caused by anisometropia is corrected using corrective lenses but image size differences (aniseikonia) also caused by anisometropia are often ignored. This study is designed to investigate whether correcting for image size difference as well as image defocus, during the initial glasses only phase will reduce the need for the eye to ignore the information from one eye and improve treatment outcomes for these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98834 0
Dr Joanna Black
Address 98834 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road, Grafton
Auckland
1023
Country 98834 0
New Zealand
Phone 98834 0
+64 99232405
Fax 98834 0
Email 98834 0
j.black@auckland.ac.nz
Contact person for public queries
Name 98835 0
Mrs Jayshree South
Address 98835 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road, Grafton
Auckland
1023
Country 98835 0
New Zealand
Phone 98835 0
+64 99232405
Fax 98835 0
Email 98835 0
j.south@auckland.ac.nz
Contact person for scientific queries
Name 98836 0
Dr Joanna Black
Address 98836 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road, Grafton
Auckland
1023
Country 98836 0
New Zealand
Phone 98836 0
+64 99232405
Fax 98836 0
Email 98836 0
j.black@auckland.ac.nz

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 other documents available
Summary results
No Results