Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001519347
Ethics application status
Approved
Date submitted
25/10/2017
Date registered
31/10/2017
Date last updated
31/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of atropine eye drops on thinning of the ocular choroid induced by retinal image defocus in adults with myopia (near-sightedness)
Scientific title
Effect of atropine eye drops on choroidal thinning induced by hyperopic retinal defocus in adults with myopia
Secondary ID [1] 293214 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 305226 0
Condition category
Condition code
Eye 304528 304528 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One drop 0.5% atropine eye drop to non-dominant eye on one occasion, instilled by the research optometrist
Intervention code [1] 299469 0
Treatment: Drugs
Comparator / control treatment
Sequential no-treatment - treatment study in same eye. No additional control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303767 0
Change in sub-foveal choroidal thickness (measured with swept source optical coherence tomography) in response to imposed retinal defocus with 2.00 Dioptre lens
Timepoint [1] 303767 0
Before and 22 hours after 1 drop of 0.5% atropine
Secondary outcome [1] 340110 0
Change in para-foveal choroidal thickness (measured using swept source optical coherence tomography) in response to imposed retinal defocus with 2.00 Dioptre lens
Timepoint [1] 340110 0
before and 22 hours after 1 drop of 0.5% atropine

Eligibility
Key inclusion criteria
The inclusion criteria for this study were: Spherical Equivalent Refraction (SER) with spectacle prescription between -1.00 to -5.00 D, with little astigmatism (= 1.00 D) or anisometropia (= 1.00 D).
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with amblyopia, ocular pathology or other ocular anomalies (e.g. surgery, trauma) that might have influenced the measurements were excluded.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/11/2014
Date of last participant enrolment
Anticipated
Actual
12/03/2015
Date of last data collection
Anticipated
Actual
12/03/2015
Sample size
Target
12
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 9315 0
New Zealand
State/province [1] 9315 0
Auckland

Funding & Sponsors
Funding source category [1] 297842 0
University
Name [1] 297842 0
The University of Auckland
Country [1] 297842 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Rd
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 296880 0
None
Name [1] 296880 0
NA
Address [1] 296880 0
NA
Country [1] 296880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298889 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 298889 0
The University of Auckland
Private Bag 92019
Auckland 1142
Ethics committee country [1] 298889 0
New Zealand
Date submitted for ethics approval [1] 298889 0
Approval date [1] 298889 0
24/10/2013
Ethics approval number [1] 298889 0
010617

Summary
Brief summary
Myopia of any degree increases the risk of developing sight-threatening conditions such as glaucoma, retinal detachment and myopic maculopathy with risk increasing dramatically with progression to high myopia. Atropine eye drops are currently the most effective treatment for managing myopia progression, but the mode of action is unclear. The aim of this study was to investigate the effect of atropine eye drops on choroidal thinning induced by hyperopic retinal defocus, using automated measures of choroidal thickness obtained with swept-source optical coherence tomography (SS-OCT). A secondary aim was to record the short-term effect of atropine on the resting thickness of the choroid.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 78574 0
Dr John Phillips
Address 78574 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 78574 0
New Zealand
Phone 78574 0
+64 9 923 6073
Fax 78574 0
Email 78574 0
[email protected]
Contact person for public queries
Name 78575 0
Dr John Phillips
Address 78575 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 78575 0
New Zealand
Phone 78575 0
+64 9 923 6073
Fax 78575 0
Email 78575 0
[email protected]
Contact person for scientific queries
Name 78576 0
Dr John Phillips
Address 78576 0
School of Optometry and Vision Science
The University of Auckland
85 Park Road
Grafton
Auckland 1023
Country 78576 0
New Zealand
Phone 78576 0
+64 9 923 6073
Fax 78576 0
Email 78576 0
[email protected]

No information has been provided regarding IPD availability


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.