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Trial registered on ANZCTR


Registration number
ACTRN12620001046998p
Ethics application status
Not yet submitted
Date submitted
7/08/2020
Date registered
15/10/2020
Date last updated
15/10/2020
Date data sharing statement initially provided
15/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of adding atropine to orthokeratology on eye elongation and myopia progression in children.
Scientific title
Effect of adding atropine to orthokeratology on eye elongation and myopia progression in children.
Secondary ID [1] 301952 0
None
Universal Trial Number (UTN)
U1111-1256-5252
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia (short-sight) 318504 0
Condition category
Condition code
Eye 316508 316508 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of atropine (0.025%) as the lubricant fluid used when inserting overnight orthokeratology contact lenses onto the cornea of the (experimental) eye. (The fluid normally used is saline)
Dose: one drop, once daily, for two years, when inserting lenses at night.
Administered by parent for younger children and by participant for older children: monitored by parental diary in both cases.
Cross-over between eyes at one year with no washout period (for example: right eye receives atropine for one year followed by saline for one year, whereas left eye receives saline for one year followed by atropine for one year)
Intervention code [1] 318240 0
Treatment: Drugs
Intervention code [2] 318241 0
Treatment: Devices
Comparator / control treatment
Randomized, contralateral-eye control, crossover study, using orthokeratology in both eyes, with the use of atropine 0.025% as the insertion fluid in the experimental eye and conventional saline as the insertion fluid in the control (contralateral) eye.
Control group
Placebo

Outcomes
Primary outcome [1] 324649 0
Change in axial eye length measured with non-contact ocular biometer.
Timepoint [1] 324649 0
Assessed at Baseline, 6 months, 12 months (primary timepoint), 18 months, 24 months, 30 months and 36 months after commencing intervention,
Primary outcome [2] 324650 0
Change in refractive error, measured by cycloplegic autorefraction.
Timepoint [2] 324650 0
Assessed at Baseline, 6 months, 12 months (primary timepoint), 18 months, 24 months, 30 months and 36 months after commencing intervention,
Secondary outcome [1] 385337 0
Pupil diameter, measured with pupillometer
Timepoint [1] 385337 0
Assessed at Baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months after commencing intervention,
Secondary outcome [2] 385338 0
Corneal Topography (i.e. shape of the cornea) measured with a corneal topographer.
Timepoint [2] 385338 0
Assessed at Baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months after commencing intervention,
Secondary outcome [3] 385339 0
Intraocular pressure (IOP) measured with non-contact tonometry.
Timepoint [3] 385339 0
Assessed at Baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months after commencing intervention,

Eligibility
Key inclusion criteria
Between 8 to 18 years of age
Have successfully worn Orthokeratology for more than 3 months.
Have a spectacle prescription of -0.75D to -6.00D spherical equivalent
Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A difference in prescription between the two eyes greater than 1.50 Diopters
Amblyopia, cataract or strabismus
On medication that may interact with atropine
A known allergy to anticholinergic drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed Opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size: Power calculations determined that 27 participants would be needed. Sample size was determined using power level of 0.90. Kinoshita et al. found a 0.09mm mean difference between orthokeratology + Atropine 0.01% and Orthokeratology alone groups. A previous (Anstice et al., 2011) crossover paired-eye study estimated the standard deviation for between-eyes measures as 0.08mm. We have used an estimated drop out of 15% to give 32 participants.

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 outside Australia
Country [1] 22815 0
New Zealand
State/province [1] 22815 0
Christchurch

Funding & Sponsors
Funding source category [1] 306378 0
University
Name [1] 306378 0
The University of Auckland
Address [1] 306378 0
School of Optometry and Vision Science
The University of Auckland,
Private Bag 92019, Auckland 1142.
Country [1] 306378 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
School of Optometry and Vision Science
The University of Auckland,
Private Bag 92019, Auckland 1142.
Country
New Zealand
Secondary sponsor category [1] 306895 0
None
Name [1] 306895 0
Address [1] 306895 0
Country [1] 306895 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 306575 0
Health and Disability Ethics Committee (New Zealand)
Ethics committee address [1] 306575 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306575 0
New Zealand
Date submitted for ethics approval [1] 306575 0
02/11/2020
Approval date [1] 306575 0
Ethics approval number [1] 306575 0

Summary
Brief summary
The study investigates whether there is any additional benefit of adding atropine 0.025% insertion fluid when using Orthokeratology lenses to slow the progression of myopia (short-sight) in children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104338 0
Dr John R Phillips
Address 104338 0
School of Optometry and Vision Science,
The University of Auckland,
Private Bag 92019, Auckland 1142.
Country 104338 0
New Zealand
Phone 104338 0
+64 99236073
Fax 104338 0
Email 104338 0
j.phillips@auckland.ac.nz
Contact person for public queries
Name 104339 0
Dr John R Phillips
Address 104339 0
School of Optometry and Vision Science,
The University of Auckland,
Private Bag 92019, Auckland 1142.
Country 104339 0
New Zealand
Phone 104339 0
+64 99236073
Fax 104339 0
Email 104339 0
j.phillips@auckland.ac.nz
Contact person for scientific queries
Name 104340 0
Dr John R Phillips
Address 104340 0
School of Optometry and Vision Science,
The University of Auckland,
Private Bag 92019, Auckland 1142.
Country 104340 0
New Zealand
Phone 104340 0
+64 99236073
Fax 104340 0
Email 104340 0
j.phillips@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The participants (who are children) are recruited with the understanding that their individual data remains confidential to the researchers.
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8718 0
Study protocol
Citation [1] 8718 0
Link [1] 8718 0
Email [1] 8718 0
j.phillips@auckland.ac.nz
Other [1] 8718 0
Attachment [1] 8718 0
Type [2] 8719 0
Ethical approval
Citation [2] 8719 0
Link [2] 8719 0
Email [2] 8719 0
j.phillips@auckland.ac.nz
Other [2] 8719 0
Attachment [2] 8719 0
Summary results
No Results