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Trial registered on ANZCTR


Registration number
ACTRN12617000598381
Ethics application status
Approved
Date submitted
11/04/2017
Date registered
27/04/2017
Date last updated
8/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Western Australian ATOM pilot study : Atropine for the treatment of myopia
Scientific title
A pilot study to evaluate the effectiveness of daily 0.01% atropine eye drop therapy in modifying the progression of myopia, in Australian Children.
Secondary ID [1] 291586 0
'Nil known'
Universal Trial Number (UTN)
'Nil known'
Trial acronym
WA ATOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myopia 302701 0
Condition category
Condition code
Eye 302216 302216 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.01% atropine eye drops in a vehicle solution of hydroxypropyl methylcellulose 0.5% and boric acid preservative. Administered 1 drop per day, to both eyes, at night for 24 months.
Returned eye drop bottles will be evaluated for volume used over time. It will also be recommended that patents/carers record any accidental missed doses wherever possible in the study diaries provided.
Intervention code [1] 297655 0
Treatment: Drugs
Comparator / control treatment
The Placebo eye drops will be the vehicle solution of hydroxypropyl methylcellulose 0.5% and boric acid preservative. Administered once per day, to both eyes, at night for 24 months.
Control group
Placebo

Outcomes
Primary outcome [1] 301629 0
Mean change in spherical equivalent refractive error measured by a cycloplegic auto refractor Nidek ARK-510A.
Timepoint [1] 301629 0
6 month visits throughout the 24 month study period
Secondary outcome [1] 333332 0
Amplitude of accommodation measured using a Royal Air Force ruler.
Timepoint [1] 333332 0
6 month visits throughout the 24 month study period
Secondary outcome [2] 333333 0
Choroidal thickness determined by optical coherence tomography (OCT) Spectralis.
Timepoint [2] 333333 0
6 month visits throughout the 24 month study period
Secondary outcome [3] 333334 0
Corneal curvature and axial length will be auto-measured by the Zeiss IOL Master 500.
Timepoint [3] 333334 0
6 month visits throughout the 24 month study period
Secondary outcome [4] 333335 0
Wilkins Rate of Reading test comparisons between baseline reading rate and treatment end rates, to determine whether the treatment affects the reading ability of children.
Timepoint [4] 333335 0
At baseline and at 24months
Secondary outcome [5] 333336 0
Intraocular pressure measured using a tonometer.
Timepoint [5] 333336 0
6 month visits throughout the 24 month study period
Secondary outcome [6] 333924 0
Stereovision assess by a Titmus chart.
Timepoint [6] 333924 0
6 month visits throughout the 24 month study period
Secondary outcome [7] 333928 0
Parents will complete a Quality of Life assessment (PEDIG) to evaluate the feasibility and practicality of treating children with daily eye drops.
Timepoint [7] 333928 0
6 month visits throughout the 24 month study period

Eligibility
Key inclusion criteria
Aged 6-16 years
Myopia with spherical equivalent refractive error greater or equal to -1.5D in each eye
Documented myopic progression of greater or equal to -0.5D over the previous 12 months in either eye
Astigmatism less than -1.5D
An intraocular difference in spherical equivalent < 1D
Corrected visual acuity greater than logMar 0.2
Normal IOP
Normal ocular health
No history of cardiac/respiratory disease
Willing and able to provide details of parents country of origin
Able to provide appropriate parental/carer consent
Minimum age
6 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Astigmatism of 1.5D or more
1D or more anisometropia
Severe developmental delay (unable to participate in subjective refraction of testing)
Ocular comorbidities such as glaucoma, aphakia, pseudophakia, uveitis, keratoconus, connective tissue diseases (eg. Marfan syndrome, vitroretinal dystrophies)
Severe ocular surface disease
Previously received atropine treatment of amblyopia at any time in the past.

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 schedule and dispensing log will be maintained independently by the dispensing pharmacy using an interactive web-based response system (IWRS).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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)
Safety/efficacy
Statistical methods / analysis
Demographic and baseline data (best corrected visual acuity BCVA) for distance and near accommodation, cycloplegic autorefraction, subjective refraction, corneal pachymetry and curvature, choroidal thickness and axial length will be summarised by treatment group using mean and standard deviation for symmetrical distributions and median and inter-quartile range for asymmetric distributions.
Primary Aim: Detection of slowing down myopia progression.
Measurements for both eyes will be pooled and the mean and standard deviation (SD) of the ocular parameters (detailed above) calculated. To detect a change in myopia progression and other ocular parameters, treatment comparisons will be made using t-tests and Wilcoxon rank sum tests for continuous variables with symmetric and asymmetric distributions, respectively. Categorical ocular parameters will be compared between the treatment groups using Fisher's exact test.
Secondary Aim: Interaction of time spent outdoors with atropine 0.01% effectiveness
Ocular parameter data from both eyes will be pooled to give a single mean value prior to analysis suing vector generalised additive models (VGAM) to account for potential skewness and leptokurtosis in the ocular outcomes. Explanatory variables for treatment group, activity levels and baseline ocular measurements will be included and robust standard errors for clustered data will be employed.
This is a pilot study. A power calculation based on the data from the ATOM 2 study (where mean change in spherical equivalent refractive error per year was -0.28 (SD=0.92) in children treated with 0.01% atropine and -1.20 (SD=0.46) in natural myopia progression) suggests that a sample size of 54 participants can detect a similar difference between 0.01% atropine and placebo groups for children with Asian ancestry. This is based on a two-sided test, a significant level of 5% and 80% power.
A significant level of 5% will be used in all analyses.

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7777 0
Lions Eye Institute Day Surgery Centre - Nedlands
Recruitment postcode(s) [1] 15710 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 296073 0
Charities/Societies/Foundations
Name [1] 296073 0
Telethon Perth Childrens Hospital Research Fund
Address [1] 296073 0
100 Roberts Rd, Subiaco WA 6008
Country [1] 296073 0
Australia
Funding source category [2] 296128 0
Other
Name [2] 296128 0
Lions Eye Institute
Address [2] 296128 0
2 Verdun St, NEDLANDS WA 6009
Country [2] 296128 0
Australia
Primary sponsor type
Other
Name
Lions Eye Institute
Address
2 Verdun St, NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 294967 0
None
Name [1] 294967 0
Address [1] 294967 0
Country [1] 294967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297332 0
PMH HREC
Ethics committee address [1] 297332 0
Princess Margaret Hospital
Cnr Roberts Rd and Hamilton St
SUBIACO WA 6008
Ethics committee country [1] 297332 0
Australia
Date submitted for ethics approval [1] 297332 0
16/02/2017
Approval date [1] 297332 0
28/02/2017
Ethics approval number [1] 297332 0
2016131EP
Ethics committee name [2] 297419 0
UWA Human Ethics
Ethics committee address [2] 297419 0
The University of Western Australia
M459, 35 Stirling Hwy
CRAWLEY WA 6009
Ethics committee country [2] 297419 0
Australia
Date submitted for ethics approval [2] 297419 0
03/01/2017
Approval date [2] 297419 0
30/01/2017
Ethics approval number [2] 297419 0
RA/4/1/8782

Summary
Brief summary
This pilot study will be the first to report on the response of myopic (short-sighted) children living in Australia to low dose atropine treatment. It will also examine outdoor/physical activity levels to inform guidelines that balance minimizing the long term effects of myopia (short-sightedness) versus the risks of increased UV exposure.
The aim of this study is to test whether a very dilute (0.01%) solution of muscle relaxing mediation (Atropine) given as a single daily eye drop, can slow the progress of myopia. The treatment part of the study will run for 2 years.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1628 1628 0 0

Contacts
Principal investigator
Name 73730 0
Prof David Mackey
Address 73730 0
Lions Eye Institute
2 Verdun St
NEDLANDS WA 6009
Country 73730 0
Australia
Phone 73730 0
+61 8 9381 0777
Fax 73730 0
Email 73730 0
davidmackey@lei.org.au
Contact person for public queries
Name 73731 0
Dr Antony Clark
Address 73731 0
Lions Eye Institute
2 Verdun St
NEDLANDS WA 6009
Country 73731 0
Australia
Phone 73731 0
+61 8 6382 0507
Fax 73731 0
Email 73731 0
myopia@lei.org.au
Contact person for scientific queries
Name 73732 0
Dr Antony Clark
Address 73732 0
Lions Eye Institute
2 Verdun St
NEDLANDS WA 6009
Country 73732 0
Australia
Phone 73732 0
+61 8 6382 0507
Fax 73732 0
Email 73732 0
myopia@lei.org.au

No data has been provided for results reporting
Summary results
Not applicable