None listed
Conditions
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.
Interventions
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 prede
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.
Sponsors
Eyerising International Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
8 Years to 13 Years
Healthy volunteers
No
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
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
Outcome results
None listed