Trial Review

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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
Scientific title
Efficacy of repeated low-level red-light therapy in myopia control in schoolchildren: a randomized controlled trial
Secondary ID [1] 306685 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myopia 325627 0
Condition category
Condition code
Eye 322983 322983 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323131 0
Treatment: Devices
Comparator / control treatment
Subjects in the control group will wear their own single vision spectacles.
Control group
Active

Outcomes
Primary outcome [1] 330751 0
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.
Timepoint [1] 330751 0
12 months after enrolment
Secondary outcome [1] 407445 0
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.
Timepoint [1] 407445 0
1-, 3-, 6-month after enrolment.
Secondary outcome [2] 407446 0
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.
Timepoint [2] 407446 0
1-, 3-, 6-, and 12-month after enrolment.
Secondary outcome [3] 407447 0
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).
Timepoint [3] 407447 0
1-, 3-, 6-, and 12-month after enrolment.
Secondary outcome [4] 407448 0
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).
Timepoint [4] 407448 0
1-, 3-, 6-, and 12-month after enrolment.
Secondary outcome [5] 407449 0
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.
Timepoint [5] 407449 0
1-, 3-, 6-, and 12-month after enrolment.
Secondary outcome [6] 407450 0
Structual optical coherence tomography (OCT) scans.
Timepoint [6] 407450 0
1-, 3-, 6-, and 12-month after enrolment.
Secondary outcome [7] 407451 0
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.
Timepoint [7] 407451 0
1-, 3-, 6-, and 12-month after enrolment.
Secondary outcome [8] 407914 0
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).
Timepoint [8] 407914 0
1-, 3-, 6-, and 12-month after enrolment.
Secondary outcome [9] 407917 0
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).
Timepoint [9] 407917 0
1-, 3-, 6-, and 12-month after enrolment.

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
Minimum age
8 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
30/08/2022
Date of last participant enrolment
Anticipated
31/07/2023
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
108
Accrual to date
26
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311016 0
Commercial sector/Industry
Name [1] 311016 0
Eyerising International Pty Ltd
Country [1] 311016 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Eyerising International Pty Ltd
Address
Suite 2.05 9-11 Claremont Street, South Yarra, Vic 3141, Australia
Country
Australia
Secondary sponsor category [1] 312332 0
None
Name [1] 312332 0
Address [1] 312332 0
Country [1] 312332 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310564 0
The Royal Children’s Hospital Human Research Ethics Committee
Ethics committee address [1] 310564 0
50 Flemington Road Parkville Victoria 3052 Australia
Ethics committee country [1] 310564 0
Australia
Date submitted for ethics approval [1] 310564 0
03/03/2022
Approval date [1] 310564 0
25/07/2022
Ethics approval number [1] 310564 0
HREC/82296/RCHM - 2022

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118102 0
Dr Marianne Coleman
Address 118102 0
Australian College Of Optometry - Carlton Clinic, 374 Cardigan St, Carlton VIC 3053
Country 118102 0
Australia
Phone 118102 0
+61 3 9349 7423
Fax 118102 0
Email 118102 0
marianne.coleman@unimelb.edu.au
Contact person for public queries
Name 118103 0
Ms Nellie Deen
Address 118103 0
Australian College Of Optometry - Carlton Clinic, 374 Cardigan St, Carlton VIC 3053
Country 118103 0
Australia
Phone 118103 0
+61 3 9349 7423
Fax 118103 0
Email 118103 0
ndeen@aco.org.au
Contact person for scientific queries
Name 118104 0
Dr Zhuoting (Lisa) Zhu
Address 118104 0
Dr Zhuoting (Lisa) Zhu
Suite 2.05 9-11 Claremont Street, South Yarra, Vic 3141, Australia
Country 118104 0
Australia
Phone 118104 0
+61 414346698
Fax 118104 0
Email 118104 0
zhuoting.zhu@eyerisinginternational.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified IPD will be shared
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.
Available to whom?
Data is available under request.
Available for what types of analyses?
Data is available for non-commercial analysis.
How or where can data be obtained?
Data will be obtained from the PIs through +61 3 9349 7423.


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.