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Trial registered on ANZCTR


Registration number
ACTRN12618001915246
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
26/11/2018
Date last updated
4/02/2019
Date data sharing statement initially provided
26/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, observational, longitudinal study to determine key factors in the onset and progression of myopia in children
Scientific title
A prospective, observational, longitudinal study to determine key factors in the onset and progression of myopia in children
Secondary ID [1] 296599 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 310408 0
Condition category
Condition code
Eye 309123 309123 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
This is a prospective, longitudinal, observational cohort study, where the eyes of 500 children aged 4 to 15 years will be monitored every 6 months for a total duration of two years. There will be 5 to 6 scheduled visits for each participant.

Every 6 months measurements such as height and weight, visual acuity, evaluation of anterior segment using slit lamp, accommodation, crystalline lens thickness and axial length measurements using Lenstar, posterior segment evaluation (retinal and choroidal thickness) using Optical Coherence Tomography (OCT) will be performed. In addition, participants will be dilated/cyclopleged and post cycloplegic measurements such as refractive error and crystalline lens power assessments will be performed.

A minimum of 500 children from Australia, aged 4-15 years with both myopic and non-myopic refractive errors will be enrolled.

To provide adequate number of new cases of pre-myopes and myopes and to establish association with risk factors and progression, children will be enrolled into age specific intervals. Once enrolled, they will be monitored every 6 months for a total duration of 2 years.

Data from the study will be pooled from multi-sites following similar protocols. Collectively the data will be part of a prospective, longitudinal, observational cohort study with 3000 children (1400 Chinese, 550 Indian, 550 Vietnamese and 500 Australian children) aged 4 to 15 years with both myopic and non-myopic refractive errors enrolled.
Intervention code [1] 312910 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308101 0
Change in spherical equivalent (refractive error) measured using Shin-Nippon open field autorefractor
Timepoint [1] 308101 0
Baseline
12 months follow-up visit
24 months follow-up (primary end point)
Primary outcome [2] 308103 0
Change in axial length of the eye measured using Lenstar
Timepoint [2] 308103 0
Baseline
12 months follow-up
24 months follow-up (primary endpoint)
Secondary outcome [1] 354318 0
Change in anterior chamber depth measured using Lenstar
Timepoint [1] 354318 0
Baseline
12 months follow-up
24 months follow-up (secondary endpoint)

Eligibility
Key inclusion criteria
* Age in complete years ranging from 4 to 15 years, male or female.
* Vision of 20/40 or better with or without correction
* In children <10 yrs of age: Cycloplegic spherical equivalent ranging from +3.00D to -4.00D (myopia- defined as having at least -0.50D to until -4.00D; non myopia more than-0.50 to +3.00D); astigmatism less than 1.50D in either eye
* In children greater than or equal to 10 yrs of age: Cycloplegic spherical equivalent ranging from +3.00D to -5.50D (myopia- defined as having at least -0.50D to until -5.50D; non myopia >-0.50 to +3.00D); astigmatism less than 1.50D in either eye
* Have a parent or guardian who is able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent and by the participant themselves if they are able to give their own consent.
* Willing to comply with the wearing and study visit schedule as directed by the Investigator.
* Have ocular health findings considered to be “normal”.
Minimum age
4 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Have a known allergy to, or a history of intolerance to cyclopentolate or topical anaesthetics;
* Have undergone any pharmaceutical treatment for myopia control such as atropine or pirenzepine;
* Is anisometropic by more than 1.50D;
* Have strabismus and/or amblyopia;
* Have been treated with orthokeratology lenses or myopia control contact lenses prior to enrolling in study;
* Have been treated bifocal, progressive addition spectacles or Myovision spectacles prior to enrolling in study;
* Any pre-existing condition with possible associations with myopia or affecting refractive development of the eye e.g. Marfan's syndrome, retinopathy of prematurity, diabetes;
* Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
* Use of or a need for concurrent category S3 and above ocular medication at enrollment and/or during the study.
* Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology either in an adverse or beneficial manner at enrollment and/or during the study.
* Eye surgery within 12 weeks immediately prior to enrollment for this study.
* Previous corneal refractive surgery.
* Currently enrolled in another clinical trial.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Participants who have commenced the study treatment will be included in the analysis dataset. Reasons and frequency distribution of participants discontinued at baseline will be reported. The analysis of efficacy variables such as subjective ratings will employ only scheduled and evaluable visits. The analysis of safety variables such as adverse responses will include all visits, including all unscheduled visits. The study PI can request an analysis of only those participants who have completed the study, which has benefit for crossover type studiess. The default type of analysis will follow an Intent-to-Treat principle. The analysis plan for each primary and secondary endpoint is described here.

Myopia progression will be computed as a change in spherical equivalent and axial length from the baseline visit, Data will be summarised as means +/- standard deviations for variables measured on an interval scale and median +/- interquartile range for ordinal variables and percentages for those that are categorical. The association of age and near work / outdoor activities with progression of myopia will be analysed using linear mixed model with subject random intercepts and visits accounted as repeated effects. The effects of age and magnitude of near work / outdoor activities will be modelled after accounting for other demographic factors such as gender, parental myopia and baseline RE. The collection of statistical tests that may be used include Linear mixed model, General linear model, Generalised estimating equations, Logistic regression ordinal regression, ROC curves and survival analysis. Data from both eyes will be used and the resulting intra-subject correlation will be accounted for using mixed methods (fixed & random).

Other commonly used tests of significance at each visit may include paired t-tests and group t-test for parametric data and Wilcoxon signed-rank test and rank sum test for non-parametric data. Test of other categorical variables may include McNemar’s, Fisher’s Exact and Chi-Square tests for within- and between-participant factors.

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)
NSW
Recruitment outside Australia
Country [1] 21030 0
China
State/province [1] 21030 0
Country [2] 21031 0
India
State/province [2] 21031 0
Country [3] 21032 0
Viet Nam
State/province [3] 21032 0

Funding & Sponsors
Funding source category [1] 301177 0
Other Collaborative groups
Name [1] 301177 0
Brien Holden Vision Institute
Address [1] 301177 0
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country [1] 301177 0
Australia
Funding source category [2] 301179 0
Commercial sector/Industry
Name [2] 301179 0
Cooper Vision Inc
Address [2] 301179 0
21062 Bake Parkway #200, Lake Forest CA 92630 USA
Country [2] 301179 0
United States of America
Funding source category [3] 301180 0
Commercial sector/Industry
Name [3] 301180 0
Essilor International/Essilor AMERA
Address [3] 301180 0
201 Kallang Bahru, 03-00 Essilor Building, 339338 Singapore
Country [3] 301180 0
Singapore
Primary sponsor type
Other Collaborative groups
Name
Brien Holden Vision Institute
Address
Level 4, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 300798 0
Commercial sector/Industry
Name [1] 300798 0
Cooper Vision Inc
Address [1] 300798 0
21062 Bake Parkway #200, Lake Forest CA 92630 USA
Country [1] 300798 0
United States of America
Secondary sponsor category [2] 300800 0
Commercial sector/Industry
Name [2] 300800 0
Essilor International/Essilor AMERA
Address [2] 300800 0
201 Kallang Bahru, 03-00 Essilor Building, 339338 Singapore
Country [2] 300800 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301919 0
Bellberry Limited
Ethics committee address [1] 301919 0
129 Glen Osmond Rd
Eastwood
South Australia 5063
Ethics committee country [1] 301919 0
Australia
Date submitted for ethics approval [1] 301919 0
04/09/2018
Approval date [1] 301919 0
16/11/2018
Ethics approval number [1] 301919 0

Summary
Brief summary
The purpose of this study is to determine the risk factors related to progression of myopia in children aged 4 - 15 years by evaluating hereditary and environmental factors. The possible role of these newly found and existing factors in predicting the onset and progression of myopia in non-myopic eyes will also be determined. To achieve this, participants will be followed up for 2 years with 6 months interval. There will be a total of 5 to 6 visits for each participant.
The null hypotheses of this study are;
(i) Annual rate of myopia progression is age dependent.
(ii) Onset and progression of myopia is dependent on the magnitude and intensity of near and outdoor activities
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88558 0
Mr Daniel Tilia
Address 88558 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia

Country 88558 0
Australia
Phone 88558 0
+61 2 9385 7516
Fax 88558 0
Email 88558 0
d.tilia@brienholdenvision.org
Contact person for public queries
Name 88559 0
Prof Padmaja Sankaridurg
Address 88559 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia

Country 88559 0
Australia
Phone 88559 0
+61 2 9385 7516
Fax 88559 0
Email 88559 0
p.sankaridurg@brienholdenvision.org
Contact person for scientific queries
Name 88560 0
Prof Padmaja Sankaridurg
Address 88560 0
Level 5, North Wing,
Rupert Myers Building
Gate 14, Barker Street
UNSW Sydney NSW 2052
Australia

Country 88560 0
Australia
Phone 88560 0
+61 2 9385 7516
Fax 88560 0
Email 88560 0
p.sankaridurg@brienholdenvision.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not published. However trial results, recorded as statistical analysis may be published in scientific journals.
What supporting documents are/will be available?
No other documents available
Summary results
No Results