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Trial registered on ANZCTR
Registration number
ACTRN12622000526774
Ethics application status
Approved
Date submitted
17/03/2022
Date registered
4/04/2022
Date last updated
7/03/2023
Date data sharing statement initially provided
4/04/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy of repeated low-level red-light therapy in myopia control in schoolchildren: a randomized controlled trial
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Scientific title
Efficacy of repeated low-level red-light therapy in myopia control in schoolchildren: a randomized controlled trial
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Secondary ID [1]
306685
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myopia
325627
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Condition category
Condition code
Eye
322983
322983
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The device used in this study is a semi-conductor laser product (Eyerising International Pty Ltd, Melbourne, Australia), emitting low-level red-light with a wavelength of 650 ± 10 nm. Based on calculations done by the manufacturer, the device provides light at a power of 2.00 ± 0.50 mW. The device embedded software enables the device to connect to the internet with an automated diary function to record the date and time of treatment sessions, as well as to control light emission as per the predefined treatment schedule (3 minutes per session, 2 sessions per day, with a minimum 4-hour interval, 5 days a week, evaluated at 1 month, 3 months, 6 months, and 12 months after enrolment). The intervention period is for 12 months.
Prior to the examination, the study personnel will obtain informed consent from the parents or guardians of the subjects. Eligibility criteria will be assessed. Instruction will be subsequently provided on how to use the device through a video demonstration. The video will be provided to parents for review at any time. In addition to continuing routine activities, and wearing their own single-vision spectacles to correct myopia, subjects in the intervention group will be treated with a therapy device twice a day from Monday to Friday, three minutes per session, with a minimum interval of 4 hours, under the supervision of their parents. Each child in the intervention group will have a unique corresponding personal account and password, and the therapy device will be initiated for treatment after logging into the system prior to use.
Intervention compliance monitoring
Subjects will need to enter their unique accounts and password details and log in prior to the commencement of each treatment session. The device is connected to a centralized system via the Internet so that treatment data and compliance can be monitored centrally. Three staff members from the project members will monitor treatment compliance and usage time statistics collected once a week. The staff will remind parents/guardians of subjects who use the device less than 8 times/week to improve compliance.
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Intervention code [1]
323131
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Treatment: Devices
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Comparator / control treatment
Subjects in the control group will wear their own single vision spectacles.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in Axial Length measured at the 12-month follow-up visit compared to baseline. Five measures of AL will be conducted on each eye prior to cycloplegia using partial coherence interferometry IOLMaster (Carl Zeiss 500, Meditec, Oberkochen, Germany) and averaged if the desired precision (i.e., < 0.10 mm) is achieved.
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Assessment method [1]
330751
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Timepoint [1]
330751
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12 months after enrolment
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Secondary outcome [1]
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Change in Axial Length (AL) measured at the 1-, 3-, 6-month follow-up visit compared to baseline. Five measures of AL will be conducted on each eye prior to cycloplegia using partial coherence interferometry IOLMaster (Carl Zeiss 500, Meditec, Oberkochen, Germany) and averaged if the desired precision (i.e., < 0.10 mm) is achieved.
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Assessment method [1]
407445
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Timepoint [1]
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1-, 3-, 6-month after enrolment.
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Secondary outcome [2]
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Cycloplegic spherical equivalent refraction (SER, myopia progression) measured at baseline compared to the 1-, 3-, 6- and 12-month follow-up visits. Refraction data will be measured at each eye using an autorefractor (KR-8800, Topcon, Tokyo, Japan) three times and averaged if the desired precision (i.e., spherical and cylindrical power < 0.25 D, axis < 5 degree) is achieved. Cycloplegia will be achieved using 1 drop of 0.5% Alcaine (Alcon, Puurs, Belgium) followed by 3 drops of 1% cyclopentolate (Alcon, Puurs, Belgium) to each eye at 0, 5, and 20 minutes. Pupil light reflex and pupil diameter will be checked to confirm full cycloplegia. The SER is calculated by using the sum of the spherical power and half of the cylindrical power.
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Assessment method [2]
407446
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Timepoint [2]
407446
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1-, 3-, 6-, and 12-month after enrolment.
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Secondary outcome [3]
407447
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Corneal curvature (CC) measured at baseline compared to the 1-, 3-, 6- and 12-month follow-up visits. Five measures of CC will be conducted on each eye prior to cycloplegia using partial coherence interferometry IOLMaster (Carl Zeiss 500, Meditec, Oberkochen, Germany).
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Assessment method [3]
407447
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Timepoint [3]
407447
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1-, 3-, 6-, and 12-month after enrolment.
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Secondary outcome [4]
407448
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Visual acuity (uncorrected visual acuity (UCVA) and best-corrected visual acuity (BCVA)) measured at baseline compared to the 1-, 3-, 6- and 12-month follow-up visits. Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) will be assessed at 4 meters by trained optometrists using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart (Precision Vision, Villa Park, Illinois, USA). The examination protocol is the same as the protocol used in the Refractive Error Study in Children (which was a multi-country, population-based study in children organized by the World Health Organization).
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Assessment method [4]
407448
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Timepoint [4]
407448
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1-, 3-, 6-, and 12-month after enrolment.
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Secondary outcome [5]
407449
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Self-reported adverse events (AE). A questionnaire specifically designed for this study on adverse events following the intervention will be administered at each follow-up visit and unexpected visits for the subjects in the intervention group. Subjects and their parents/guardians will be asked about the adverse events, including but not limited to short-term glare, flash blindness, and afterimages.
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Assessment method [5]
407449
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Timepoint [5]
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1-, 3-, 6-, and 12-month after enrolment.
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Secondary outcome [6]
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Structual optical coherence tomography (OCT) scans.
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Assessment method [6]
407450
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Timepoint [6]
407450
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1-, 3-, 6-, and 12-month after enrolment.
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Secondary outcome [7]
407451
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Choroidal thickness (ChT) measured at baseline compared to the 1-, 3-, 6-, and 12-month follow-up visits. For choroidal thickness (ChT), participants will undergo optical coherence tomography with pupil dilation and under standardized mesopic light conditions at the baseline examination and each follow-up visit. The thickness (the distance between outer choroid-scleral margin and RPE-Bruch’s complex) will be obtained automatically with the assistance of OCT software.
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Assessment method [7]
407451
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Timepoint [7]
407451
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1-, 3-, 6-, and 12-month after enrolment.
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Secondary outcome [8]
407914
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Anterior chamber depth (ACD) measured at baseline compared to the 1-, 3-, 6-, and 12-month follow-up visits. Five measures of ACD will be conducted on each eye prior to cycloplegia using partial coherence interferometry IOLMaster (Carl Zeiss 500, Meditec, Oberkochen, Germany).
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Assessment method [8]
407914
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Timepoint [8]
407914
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1-, 3-, 6-, and 12-month after enrolment.
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Secondary outcome [9]
407917
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White-to-white (WTW) pupil diameter measured at baseline compared to the 1-, 3-, 6-, and 12-month follow-up visits. Five measures of ACD will be conducted on each eye prior to cycloplegia using partial coherence interferometry IOLMaster (Carl Zeiss 500, Meditec, Oberkochen, Germany).
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Assessment method [9]
407917
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Timepoint [9]
407917
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1-, 3-, 6-, and 12-month after enrolment.
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Eligibility
Key inclusion criteria
1) Provision of consent
2) Age: >=8 and <= 13 years at enrolment
3) Myopia: Spherical equivalent refractions (SERs) under cycloplegia: -1.00 to -5.00 diopters (D)
4) Astigmatism of 2.50 D or less
5) Anisometropia of 1.50 D or less
6) Corrected monocular logMAR visual acuity (VA): 1.0 or better
7) Consent to participate in random allocation of grouping
8) Fluent in English
9) Willing and able to participate in all required activities of the study
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Minimum age
8
Years
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Maximum age
13
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Strabismus and binocular vision abnormalities in either eye
2) Ocular abnormalities in either eye or other systemic abnormalities that affect participate in all required activities of the study.
3) Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
4) Other reasons, including but not limited to severe physical and cognitive disability, that the physician may consider inappropriate for enrolment
5) Noncompliance with treatment
6) Children whose parents do not sign informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/05/2022
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Actual
30/08/2022
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Date of last participant enrolment
Anticipated
31/07/2023
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Actual
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Date of last data collection
Anticipated
31/07/2024
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Actual
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Sample size
Target
108
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Accrual to date
26
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
311016
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Commercial sector/Industry
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Name [1]
311016
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Eyerising International Pty Ltd
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Address [1]
311016
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Suite 2.05 9-11 Claremont Street, South Yarra, Vic 3141, Australia
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Country [1]
311016
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Eyerising International Pty Ltd
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Address
Suite 2.05 9-11 Claremont Street, South Yarra, Vic 3141, Australia
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Country
Australia
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Secondary sponsor category [1]
312332
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None
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Name [1]
312332
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Address [1]
312332
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Country [1]
312332
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310564
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The Royal Children’s Hospital Human Research Ethics Committee
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Ethics committee address [1]
310564
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50 Flemington Road Parkville Victoria 3052 Australia
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Ethics committee country [1]
310564
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Australia
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Date submitted for ethics approval [1]
310564
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03/03/2022
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Approval date [1]
310564
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25/07/2022
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Ethics approval number [1]
310564
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HREC/82296/RCHM - 2022
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Summary
Brief summary
Myopia, also known as short-sightedness, is the most common eye disorder of school-aged children globally, but current methods for controlling myopia progression have limitations for the global control of myopia. Based on our previous findings on the protective effects of increased light intensity of outdoor time, we are proposing an innovative solution, which enables relatively higher energies of light to be delivered on the fundus at much shorter durations of exposure to induce the myopia control effect. This trial is a single-centre, multi-ethnic, single-blind, parallel-group RCT with a 1:1 allocation of intervention (RLRL+SVS) and control subjects (SVS), aiming at providing evidence to evaluate this innovative treatment as a novel solution for myopia control in multi-ethnic children. We hypothesize that RLRL would significantly slow the progression of axial elongation and refraction in multi-ethnic children.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Marianne Coleman
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Address
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Australian College Of Optometry - Carlton Clinic, 374 Cardigan St, Carlton VIC 3053
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Country
118102
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Australia
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Phone
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+61 3 9349 7423
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Fax
118102
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Email
118102
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[email protected]
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Contact person for public queries
Name
118103
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Nellie Deen
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Address
118103
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Australian College Of Optometry - Carlton Clinic, 374 Cardigan St, Carlton VIC 3053
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Country
118103
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Australia
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Phone
118103
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+61 3 9349 7423
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Fax
118103
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Email
118103
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[email protected]
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Contact person for scientific queries
Name
118104
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Zhuoting (Lisa) Zhu
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Address
118104
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Dr Zhuoting (Lisa) Zhu
Suite 2.05 9-11 Claremont Street, South Yarra, Vic 3141, Australia
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Country
118104
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Australia
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Phone
118104
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+61 414346698
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Fax
118104
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Email
118104
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
de-identified IPD will be shared
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When will data be available (start and end dates)?
Data will be available starting from one year after the completion of the study, with no end date.
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Available to whom?
Data is available under request.
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Available for what types of analyses?
Data is available for non-commercial analysis.
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How or where can data be obtained?
Data will be obtained from the PIs through +61 3 9349 7423.
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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
No additional documents have been identified.
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