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Trial registered on ANZCTR


Registration number
ACTRN12617000620325
Ethics application status
Approved
Date submitted
13/04/2017
Date registered
1/05/2017
Date last updated
1/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A descriptive study on prediction of myopic progression in Australian population
Scientific title
Peripheral refractive error profile and optic disc parameters in refractive error groups
Secondary ID [1] 291698 0
CRTC-2016-03

Clinical Research Trials Centre (CRTC) of the Brien Holden Vision Institute in Sydney
Universal Trial Number (UTN)
U1111-1195-4822
Trial acronym
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Myopia 302868 0
Hyperopia 302910 0
Condition category
Condition code
Eye 302347 302347 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnostic instruments will be used to measure parameters like refractive status of the eye and posterior surface of the eye in detail (retina and optic nerve head),
3 repeat measurements will be obtained from the instruments used to analyze the peripheral refraction Brien Holden vision Institute (BHVI) eye mapper and Shin Nippon Auto Refractor. The order of testing with these 2 instruments will be randomized .
This will be a single examiner study.
Study location Brien Holden Clinical Research and Trial Centre
Duration of this single visit study will be 60 to 90 minutes
The entire study is planned to be completed within 6 to 9 months of the study period
Intervention code [1] 297831 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301769 0
Peripheral refraction profile will be assessed using BHVI (Brien Holden Vision Institute)Eye Mapper and Shin Nippon Autorefractor
Timepoint [1] 301769 0
The duration of testing of the above mentioned values may extend from 15- 20 minutes. The entire visit of the participant is scheduled for 60 to 90 minutes.
Primary outcome [2] 301885 0
The posterior surface of the eye (retinal and choroid layer ) measurements will be obtained using Optical Coherence Tomography
Timepoint [2] 301885 0
The duration of testing of the above mentioned values may extend from 10- 15 minutes. The entire visit of the participant is scheduled for 60 to 90 minutes.
Primary outcome [3] 301912 0
Optic nerve head measurements will be obtained using Optical Coherence Tomography
Timepoint [3] 301912 0
The duration of testing of the above mentioned values may take 5 minutes or less
Secondary outcome [1] 333804 0
The optic disc tilt and torsion measurements will be performed during the optic nerve head measurements are acquired as a primary outcome. Optic disc tilt and torsion are composite secondary outcomes. These measurement obtained using the Optical Coherence Tomography will be compared between different refractive groups such as myopia, hyperopia and emmetropia. Multiple logistic regressions will be used to analyze differences between these values.
Timepoint [1] 333804 0
These measurements obtained while acquiring the primary outcome values itself. However the analyses will be performed as a secondary outcome.
Secondary outcome [2] 334192 0
As a secondary outcome repeatability of the 2 instruments Shin Nippon Auto-refractor and BHVI Eye Mapper will be tested. Peripheral refraction values between 2 instruments (BHVI EYe mapper and Shin Nippon Auto Refarctor will be compared between instruments using paired t-test. The within-patient standard deviation from the 3 repeats will be compared between instruments using Levene's test for equality of variance.
Timepoint [2] 334192 0
These measurements obtained while acquiring the primary outcome values itself. However the analyses will be performed as a secondary outcome.

Eligibility
Key inclusion criteria
Healthy participants enrolled in the trial must be male or female aged between 18- 39 years, must have provided an informed consent, can be an emmetrope, hyperope or myopia , be willing to comply with clinical trial visit schedule as directed by the investigator, have ocular health findings considered to be “normal” and no anterior segment or posterior segment condition other than refractive error, have best corrected visual acuity to at least 6/9.5 or better in each eye with spectacles or contact lenses, have clear media for obtaining refractive error measurements and optic disc images
Minimum age
18 Years
Maximum age
39 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants enrolled in the trial must not have astigmatism >/= 0.75 , should not be aged 40 years or older, should not have a history of any systemic diseases including diabetes, hypertension, cardiac problems etc, any refractive or ocular surgeries, using orthokeratology lenss, any other ocular pathology, ocular hypertension or glaucoma in either eye and intra ocular pressure >/= 21 mm of Hg

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Since, there are no studies similar to this available in the literature to the best of my knowledge, a pilot study will be calculated and a post hoc power analysis will be performed later to analyse the power of the study

Kolmogorov-Smirnov test will be applied to assess the normality of data distribution. Descriptive statistics of the data will be analyzed depending on the type of distribution of the data. On achieving normality, the data set will be described using mean and standard deviation. If the data set is not normally distributed, then median and range will be used to describe the data.The within-patient standard deviation from the 3 repeats will be compared between instruments using Levene's test for equality of variance. .

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 in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296196 0
Other
Name [1] 296196 0
Brien Holden Vision Institute
Address [1] 296196 0
Level 5, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052
Country [1] 296196 0
Australia
Primary sponsor type
Other
Name
Brien Holden Vision Institute
Address
Level 5, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052
Country
Australia
Secondary sponsor category [1] 295107 0
None
Name [1] 295107 0
Address [1] 295107 0
Country [1] 295107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297437 0
Human Research Ethics Committee (HREC) The University of New South Wales
Ethics committee address [1] 297437 0
Human Research Ethics Committee (HREC)
The University of New South Wales
UNSW Sydney, NSW, Australia, 2052
Ethics committee country [1] 297437 0
Australia
Date submitted for ethics approval [1] 297437 0
16/09/2016
Approval date [1] 297437 0
02/11/2016
Ethics approval number [1] 297437 0
HC16815

Summary
Brief summary
BACKGROUND
Myopia is defined as a refractive anomaly of the eye where parallel rays of light from an object at optical infinity are focused in front of the retina when accommodation is at rest. In recent years, the prevalence of myopia has increased dramatically especially in the East Asian population. In the year 2000, the prevalence of myopia was estimated to be 21% in 7 year olds, 61% in 12 year olds and a disturbingly high 81% in 15-year-old Taiwanese school children. While evaluating the causes of visual impairment and blindness in a group of adult Chinese in urban and rural region, it was found that 32.7% was contributed by degenerative myopia. However, the rapid and disturbing increase in the prevalence rates of high myopia over the years’ warrants amending our current knowledge on myopia. The distribution of peripheral refraction profile across different meridians and whether the pattern of distribution of the peripheral refraction can predict the progression of myopia needs to be investigated. The current study is planned to investigate up on a number of optic disc parameters to determine if there is an association between features such as tilt, torsion, RNFL thickness and choroidal thickness and progression of myopia. Analyzing this relationship will help in predicting myopia at an early stage.
PURPOSE OF THE STUDY
Correlating the peripheral refraction profile and structural variations in the optic disc in different meridians will guide us in identifying potential predictive factors responsible for the progression of myopia.
The aim of this study is to determine if risk of progression of myopia can be identified using peripheral refractive error profile, optic disc features and retinal and choroidal thicknesses.
STUDY DESIGN
A cross sectional and interventional pilot study will be conducted as a first step to derive the required sample size and refine the experimental methods. The sample population aimed for this study is an age group between 18 to 39 years.
The study sample will include a minimum of 20 participants to up to 50 participants in individual subgroups of emmetropia, hyperopia and myopia is planned for this pilot study.
STUDY METHODS
Preliminary examinations will be carried out in order to screen the individuals who fit into the eligibility criteria. The initial examinations included a routine ocular examination comprising detailed history taking, measurement of objective and subjective refraction values, anterior and posterior segment examination and measurement of intra ocular pressures.
Participants who meet the inclusion criteria will undergo Shin Nippon auto-refractor and BHVI Eye-Mapper assessments for peripheral refraction profile at different field angles. The order of testing with these 2 instruments will be randomized using http://www.graphpad.com/quickcalcs/index.cfm online software. 3 repeat measurements will be obtained from both the instruments during the assessment by same examiner.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74038 0
A/Prof Padmaja Sankaridurg
Address 74038 0
Level 4, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052
Country 74038 0
Australia
Phone 74038 0
+61 2 9385 7485
Fax 74038 0
Email 74038 0
p.sankaridurg@brienholdenvision.org
Contact person for public queries
Name 74039 0
A/Prof Padmaja Sankaridurg
Address 74039 0
Level 4, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052
Country 74039 0
Australia
Phone 74039 0
+61 2 9385 7485
Fax 74039 0
Email 74039 0
p.sankaridurg@brienholdenvision.org
Contact person for scientific queries
Name 74040 0
A/Prof Padmaja Sankaridurg
Address 74040 0
Level 4, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052
Country 74040 0
Australia
Phone 74040 0
+61 2 9385 7485
Fax 74040 0
Email 74040 0
p.sankaridurg@brienholdenvision.org

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