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Trial registered on ANZCTR


Registration number
ACTRN12620000052932
Ethics application status
Approved
Date submitted
20/12/2019
Date registered
22/01/2020
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Date results information initially provided
22/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Combined effect of atropine eye drops and retinal defocus on the thickness of the ocular choroid in children with myopia.
Scientific title
Combined effect of atropine eye drops and retinal defocus on the thickness of the ocular choroid in children with myopia .
Secondary ID [1] 300145 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 315675 0
Condition category
Condition code
Eye 313964 313964 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: Atropine eye drops. Concentration 0.3%; one drop administered to the participant by the parent/caregiver to each eye, every night before sleep, for 6 months.

Intervention 2: Optical defocus to the retina of one (experimental) eye for periods of 60 minutes. Experimental eye pseudorandomly assigned: remains the same throughout the study. Degree of defocus +2.00 and -2.00 dioptres applied to experimental eye on two successive days; defocus applied with ophthalmic lenses. Administered by research optometrist before initiating atropine treatment, then (over two successive days only) at one week, 3 months and 6 months during atropine treatment. Compliance to intervention 1 assessed by questionnaire to parent at each visit. Intervention 2 administered directly by research optometrist in clinic.
Intervention code [1] 316415 0
Treatment: Drugs
Intervention code [2] 316416 0
Treatment: Other
Comparator / control treatment
Paired eye study. Both experimental eye and contralateral eyes receive intervention 1, but only the experimental eye receives intervention 2, so contralateral eye is control.
Control group
Active

Outcomes
Primary outcome [1] 322370 0
Change in thickness of the choroid as measured from Optical Coherence Tomography scans of the posterior eye. Scans conducted by research optometrist. Measures made from scans by masked observers.
Timepoint [1] 322370 0
Baseline, 1 week, 3 months and 6 months, post-intervention 1 commencement.
Secondary outcome [1] 378249 0
Amplitude of accommodation, measured with push-up test by research optometrist.
Timepoint [1] 378249 0
Baseline, 1 week, 3 months and 6 months post-intervention 1 commencement.
Secondary outcome [2] 378250 0
Pupil diameter, measured with pupilometer by research optometrist.
Timepoint [2] 378250 0
Baseline, 1 week, 3 months and 6 months post-intervention 1 commencement.

Eligibility
Key inclusion criteria
Spherical Equivalent Refractive error (myopia) between -0.75 D and -4.50 D and visual acuity of at least 0.0 logMAR.
Minimum age
6 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with any known ocular pathology, astigmatism in either eye greater than -1.00 DC, anisometropia greater than 1.00 D, or a history of pharmacological myopia control.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Paired-eye design. Atropine treatment to both eyes, but optical defocus restricted to one (experimental) eye, with contralateral eye acting as control. Experimental eye pseudo-randomly assigned to be either the dominant or non-dominant eye (dominance determined with a pointing task) using a permuted-block design.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Number of participants determined from measurement variance in a previous similar study in adults (ACTRN12617001519347). Choroidal thickness changes resulting from optical defocus measured as absolute changes from baseline of the relevant 60-minute observation period. Pair-wise comparisons of choroidal thickness changes after 60 minutes of defocus compared with paired t-tests, using Bonferroni correction, with p = 0.05 as significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/09/2015
Date of last participant enrolment
Anticipated
Actual
2/01/2016
Date of last data collection
Anticipated
Actual
6/07/2016
Sample size
Target
22
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 22195 0
New Zealand
State/province [1] 22195 0
Country [2] 22196 0
Taiwan, Province Of China
State/province [2] 22196 0

Funding & Sponsors
Funding source category [1] 304580 0
University
Name [1] 304580 0
The University of Auckland
Country [1] 304580 0
New Zealand
Funding source category [2] 304582 0
University
Name [2] 304582 0
Asia University
Country [2] 304582 0
Taiwan, Province Of China
Primary sponsor type
University
Name
The University of Auckland
Address
School of Optometry and Vision Science
85 Park Road, Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 304866 0
University
Name [1] 304866 0
Asia University
Address [1] 304866 0
500, Liufeng Road, Wufeng District
Taichung City, Taiwan 41354
Country [1] 304866 0
Taiwan, Province Of China
Other collaborator category [1] 281120 0
Individual
Name [1] 281120 0
Samuel Chiang
Address [1] 281120 0
Department of Optometry, Asia University
500, Liufeng Road, Wufeng District
Taichung City, Taiwan 41354
Country [1] 281120 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305006 0
Research Ethics Committee of China Medical University & Hospital
Ethics committee address [1] 305006 0
No. 2, Yude Road, North District
Taichung City, Taiwan 404
Ethics committee country [1] 305006 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 305006 0
13/08/2015
Approval date [1] 305006 0
15/09/2015
Ethics approval number [1] 305006 0
CMUHREC No: CMUH104-REC3-069

Summary
Brief summary
The aim of the study is to determine whether a combined therapy of atropine eye drops together with myopic retinal defocus delivered simultaneously with an ophthalmic lens to the retina of a myopic child will slow myopia progression more effectively than either therapy alone. Both atropine and myopic defocus independently cause thickening of the human choroid. This study investigates whether the choroidal thickening produced by simultaneous presentation of myopic defocus and atropine is greater than the thickness changes induced by each technique alone. A finding of superposition (summation of effects) would imply that the efficacy of myopia control based on imposing myopic defocus to the retina could be increased by simultaneous administration of atropine.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98942 0
Dr John R Phillips
Address 98942 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road, Grafton
Auckland 1023
Country 98942 0
New Zealand
Phone 98942 0
+64 99236073
Fax 98942 0
Email 98942 0
[email protected]
Contact person for public queries
Name 98943 0
John R Phillips
Address 98943 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road, Grafton
Auckland 1023
Country 98943 0
New Zealand
Phone 98943 0
+64 99236073
Fax 98943 0
Email 98943 0
[email protected]
Contact person for scientific queries
Name 98944 0
John R Phillips
Address 98944 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road, Grafton
Auckland 1023
Country 98944 0
New Zealand
Phone 98944 0
+64 99236073
Fax 98944 0
Email 98944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
beginning immediately following publication and no end date.
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Link: https://researchspace.auckland.ac.nz/handle/2292/34882


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.