None listed
Conditions
Brief summary
Compared to other myopia interventions, Repeated Low-level Red-Light therapy has shown superior effectiveness in pre-myopia and high myopia as well as, small but significant shortening of axial length. Currently, there is no evidence that once-daily RLRL therapy is as effective as twice-daily standard therapy. If once-daily treatment proves equally effective, it would reduce exposure by half, potentially minimising long-term side effects.
Interventions
Light therapy using a semiconductor laser diode emitting low-level red light at a wavelength of 650 ± 10 nm, with an illuminance of 1600 lux and a light intensity of 0.290 mW.
Intervention: RLRL standard energy emission 3 minutes once daily, 5 days a week for 12 months.
The intervention will be self-administered at home using a handheld device, under the guidance of registered eye care professionals, including optometrists and ophthalmologists.
Patients will be instructed to look inside the tar
Light therapy using a semiconductor laser diode emitting low-level red light at a wavelength of 650 ± 10 nm, with an illuminance of 1600 lux and a light intensity of 0.290 mW. Intervention: RLRL standard energy emission 3 minutes once daily, 5 days a week for 12 months. The intervention will be self-administered at home using a handheld device, under the guidance of registered eye care professionals, including optometrists and ophthalmologists. Patients will be instructed to look inside the target during the treatment period. The device keeps record of patient usage. When compliance drops below 75%, the system sends reminder message to the patient's parents and eye care professionals. The device also shuts down for 4 hours after the first use to ensure the twice a day administration is at least 4 hours apart. The family will also have a clinic contact to ensure any concern of device problems can be reported.
Sponsors
University of Canberra
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 16 Years
Healthy volunteers
No
Inclusion criteria
Participants aged 8 to 16 years with high progressive myopia, defined as axial length of 25mm or greater and axial length progression of more than 0.1 mm/6 months on conventional myopic treatment as defined below: High myopes who are undergoing conventional myopia control treatment, defined as having trialled refractive control, including myopia-control spectacles (e.g. Essilor Stellest or Hoya MiYOSMART) or contact lenses (e.g. CooperVision MiSight), and/or low-dose atropine up to 0.05% concentration, with axial length progression greater than 0.1 mm/6 months. If participants' myopia treatment includes atropine eye drops, atropine treatment must be ceased, and RLRL started after the pupil becomes reactive, with a maximum diameter of 4 mm, assessed by an Infrared Pupillometer (e.g., NeurOptics NPi-200).
Exclusion criteria
Participants with the following conditions will be excluded from the study: Manifest deviation (exotropia or esotropia) at near. Participants with known syndromic myopia, including but not exclusive to Marfan syndrome, Stickler syndrome, retinopathy of prematurity and known retinal dystrophies. Participants with any systemic diseases that may affect the study, including but not exclusive epilepsy. Participants wearing orthokeratology as the corneal remodelling from orthokeratology treatment may affect the RLRL therapy, particularly its intensity reaching the eye.
Outcome results
None listed