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Trial registered on ANZCTR


Registration number
ACTRN12617000812392
Ethics application status
Approved
Date submitted
24/05/2017
Date registered
2/06/2017
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Date results information initially provided
6/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kidskin II Study
15 year follow-up of Western Australian Kidskin Study to determine impact on myopia in early adulthood.
Scientific title
Does Modification of Time Spent Outdoors During Childhood Affect Myopia in Early Adulthood.A Follow up of the Western Australian Kidskin Study
Secondary ID [1] 291959 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
Original Kidskin Study.
Milne E, English DR, Johnston R, Cross D, Borland R, Costa C, et al. Improved sun protection behaviour in children after two years of the Kidskin intervention. Australian and New Zealand journal of public health. 2000;24(5):481-7. Epub 2000/12/08.

Health condition
Health condition(s) or problem(s) studied:
Myopia 303307 0
skin health 303340 0
Condition category
Condition code
Eye 302746 302746 0 0
Normal eye development and function
Human Genetics and Inherited Disorders 302747 302747 0 0
Other human genetics and inherited disorders
Public Health 302748 302748 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We aim to assess myopia or short-sightedness rates in approx. 900 to 1776 original young adult participants, who were part of the Western Australian Kidskin Study while they were in primary school in the 1990s. The Kidskin study intervention resulted in a reduction in time spent outdoors and an increase in the use of sun protection while outdoors. We wish to now investigate the possible impact that this intervention has had on the development of myopia in these participants who are now young adults.

To gather the data we would like to repeat during one follow-up visit, some of the questions and measures that we performed in the original Kidskin Study, approximately 15 years ago. This includes completing a questionnaire, undertaking a comprehensive eye examination, have naevi counts, and we will also ask to provide a blood sample.
Schools in the intervention groups received a multicomponent intervention. Both the moderate and high intervention groups were taught a specially designed sun protection curriculum.
Intervention code [1] 298089 0
Not applicable
Comparator / control treatment
An initial cohort of 1776 children from 33 schools in Perth was recruited in 1995 and followed up after 4 years and again after 6 years. Children were assigned to 1 of 3 groups: A control group, a moderate intervention group or a high-intervention group. Schools in the control group received the standard health curriculum.
Control group
Active

Outcomes
Primary outcome [1] 302139 0
Visual acuity: Reading letters on a eye chart. LogMAR chart (EDTRS chart)
Timepoint [1] 302139 0
Once
Secondary outcome [1] 334918 0
Short or longsighted: A composite outcome using a autorefractor (Nidek ARK-510A) will determine this and whether you require glasses.
Timepoint [1] 334918 0
Once
Secondary outcome [2] 334919 0
Eye movements: focusing on a near target and then cover each eye alternatively. The test is then repeated up close. This will determine if the eyes are straight or if an eye turn is present.
Timepoint [2] 334919 0
Once
Secondary outcome [3] 334920 0
Stereopsis: Using a 3D card to assess depth perception or seeing things in three dimensions.
Timepoint [3] 334920 0
Once
Secondary outcome [4] 334921 0
Ocular dominance: To see if one eye is used more that the other eye.
A person's dominant eye is determined subjectively by alignment of two objects presented at a stereo disparity far beyond Panum's area. There are a number of tests available, but the method of choice in this study is the Miles test.
Timepoint [4] 334921 0
Once
Secondary outcome [5] 334922 0
Ultra violet photography: Photos will be taken of the eye to assess UV damage to the front of the eye.
Timepoint [5] 334922 0
Once
Secondary outcome [6] 334923 0
Eye colour photos: Taking photos of the eye colour.
Timepoint [6] 334923 0
Once
Secondary outcome [7] 334924 0
Axial length: an ultrasound machine will measure the length of the eye from back to front.
Timepoint [7] 334924 0
Once.
Secondary outcome [8] 334925 0
Central corneal thickness: A pachymeter is a medical device used to measure the thickness of the eye's cornea.
Timepoint [8] 334925 0
Once
Secondary outcome [9] 334928 0
Intra Ocular Pressure: To measure the pressure of the fluid in the eye a Icare TAO1i Tonometer will be used.
Timepoint [9] 334928 0
Once
Secondary outcome [10] 334929 0
Photographs of the back of the eye to examine the anatomy of the retina and optic disk to determine if myopia is associated with other markers of outdoor activity eg. pterygium, melanocytic naevi counts and melanocytic naevus trajectory: A Canon CF-60DSI Digital Fundus Camera will be used for this assessment.
Timepoint [10] 334929 0
Once.
Secondary outcome [11] 334930 0
Blood pressure measurements: A blood pressure monitor will be used to get an accurate reading.
Timepoint [11] 334930 0
6 times with 2 minutes resting periods.
Secondary outcome [12] 334931 0
Measuring height and weight: Stadiometer for height and Digital Scales for weight.
Timepoint [12] 334931 0
Once
Secondary outcome [13] 334932 0
Blood or if patient prefers a saliva sample to look specifically at epigenetics which looks at how external factors might influence the packaging of DNA, an exploratory outcome:
Two 10ml EDTA blood collection tubes for DNA sampling.
Timepoint [13] 334932 0
Once.
Secondary outcome [14] 334933 0
The Kidskin II Questionnaire which was designed for this study: A measure for the time spent indoors.
Timepoint [14] 334933 0
Once
Secondary outcome [15] 335290 0
Eyelid position photos: To determine the symmetry between the eyes and also the parts around eyes including the eye lid.
Timepoint [15] 335290 0
Once
Secondary outcome [16] 335463 0
To detect sun damage areas eg. pterygium: Using a camera the Conjunctival autofluorescence photography will be used for this assessment.
Timepoint [16] 335463 0
Once
Secondary outcome [17] 335464 0
Melanocytic naevi count: A research assistant will count the number of naevi on your right arm and back.
Timepoint [17] 335464 0
Once
Secondary outcome [18] 335465 0
Dorsal hand skin wrinkling/skin impression: Using dental paste an impression of the back of the hand will be taken.
Timepoint [18] 335465 0
Once
Secondary outcome [19] 335466 0
Blood or if patient prefers a saliva sample to assess the Vitamin D levels (serum 25 (OH)D3): One serum 3.5ml SST gel tube for Vitamin D analysis.
Timepoint [19] 335466 0
Once

Eligibility
Key inclusion criteria
Participation in the initial Kidskin Study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unconsenting participants.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis
Aim 1 analysis: (a) Myopia rates will be compared between the control and intervention groups (on an intent-to =treat basis) using mixed effects logistic regression, adjusting for age, gender, ethnicity, parental myopia and child and parental education status and nesting by school (level 2) and family (level1) identifiers.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
1/12/2017
Actual
28/03/2019
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
900
Accrual to date
Final
303
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8024 0
Lions Eye Institute Day Surgery Centre - Nedlands
Recruitment postcode(s) [1] 16010 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 296474 0
Other
Name [1] 296474 0
Lions Eye Institute
Country [1] 296474 0
Australia
Funding source category [2] 296496 0
Charities/Societies/Foundations
Name [2] 296496 0
Telethon Kids Institute
Country [2] 296496 0
Australia
Primary sponsor type
Other
Name
Lions Eye Institute
Address
2 Verdun St
NEDLANDS WA 6009
Country
Australia
Secondary sponsor category [1] 295430 0
None
Name [1] 295430 0
Address [1] 295430 0
Country [1] 295430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297696 0
University of Western Australia - Human Ethics Office
Ethics committee address [1] 297696 0
35 Stirling Hwy
CRAWLEY WA 6009
Ethics committee country [1] 297696 0
Australia
Date submitted for ethics approval [1] 297696 0
01/09/2014
Approval date [1] 297696 0
23/09/2014
Ethics approval number [1] 297696 0
RA/4/1/6807

Summary
Brief summary
The aims of the Kidskin Follow up Study is to;
- Determine if there is a difference in the prevalence of myopia between children in the Kidskin intervention and control schools and whether an individual's of sun protection during childhood is associated with myopia.
- Determine if myopia is associated with other markers of outdoor activity, conjunctival UV auto-fluorescence (CUVAF), pterygium, melanocytic naevi counts and trajectory dorsal hand skin wrinkling and vitamin D levels.
- Determine which aspects of myopia-related ocular biometry are associated with the protective effect of outdoor activity.
- Investigate gene-environment interactions of myopia-risk gene-markers with sun-exposure measures.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1728 1728 0 0
/AnzctrAttachments/372950-Kidskin_Initial_Application_Approval_23102014.pdf (Ethics approval)
Attachments [2] 1729 1729 0 0
/AnzctrAttachments/372950-Kidskin_InformationSheet.pdf (Participant information/consent)

Contacts
Principal investigator
Name 74858 0
Prof David Mackey
Address 74858 0
Lions Eye Institute
2 Verdun St
Nedlands WA 6009
Country 74858 0
Australia
Phone 74858 0
+61 8 9381 0777
Fax 74858 0
Email 74858 0
davidmackey@lei.org.au
Contact person for public queries
Name 74859 0
Prof David Mackey
Address 74859 0
Lions Eye Institute
2 Verdun St
Nedlands WA 6009
Country 74859 0
Australia
Phone 74859 0
+61 8 9381 0777
Fax 74859 0
Email 74859 0
davidmackey@lei.org.au
Contact person for scientific queries
Name 74860 0
Prof David Mackey
Address 74860 0
Lions Eye Institute
2 Verdun St
Nedlands WA 6009
Country 74860 0
Australia
Phone 74860 0
+61 8 9381 0777
Fax 74860 0
Email 74860 0
davidmackey@lei.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
'NO' is selected in previous field, therefore there are no current plans to make the IPD available. However parties interested in obtaining de-identified IPD can contact the Principal Investigator.


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
SourceTitleYear of PublicationDOI
EmbaseRe-engaging an inactive cohort of young adults: evaluating recruitment for the Kidskin Young Adult Myopia Study.2020https://dx.doi.org/10.1186/s12874-020-00996-y
N.B. These documents automatically identified may not have been verified by the study sponsor.