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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]

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

Hyperopia

Condition category

Condition code

Eye

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Peripheral refraction profile will be assessed using BHVI (Brien Holden Vision Institute)Eye Mapper and Shin Nippon Autorefractor

Timepoint [1]

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]

The posterior surface of the eye (retinal and choroid layer ) measurements will be obtained using Optical Coherence Tomography

Timepoint [2]

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]

Optic nerve head measurements will be obtained using Optical Coherence Tomography

Timepoint [3]

The duration of testing of the above mentioned values may take 5 minutes or less

Secondary outcome [1]

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]

These measurements obtained while acquiring the primary outcome values itself. However the analyses will be performed as a secondary outcome.

Secondary outcome [2]

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]

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

Sex

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

3/05/2017

Actual

Date of last participant enrolment

Anticipated

31/07/2017

Actual

Date of last data collection

Anticipated

31/07/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Brien Holden Vision Institute

Address [1]

Level 5, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (HREC) The University of New South Wales

Ethics committee address [1]

Human Research Ethics Committee (HREC)
The University of New South Wales
UNSW Sydney, NSW, Australia, 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/09/2016

Approval date [1]

02/11/2016

Ethics approval number [1]

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

A/Prof Padmaja Sankaridurg

Address

Level 4, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052

Country

Australia

Phone

+61 2 9385 7485

Fax

p.sankaridurg@brienholdenvision.org

Contact person for public queries

Name

Padmaja Sankaridurg

Address

Level 4, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052

Country

Australia

Phone

+61 2 9385 7485

Fax

p.sankaridurg@brienholdenvision.org

Contact person for scientific queries

Name

Padmaja Sankaridurg

Address

Level 4, North Wing, Rupert Myers Building, Gate 14 Barker Street, University of New South Wales, UNSW NSW 2052

Country

Australia

Phone

+61 2 9385 7485

Fax

p.sankaridurg@brienholdenvision.org

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

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Documents added automatically

No additional documents have been identified.

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