Effect of Repeated Low-Level Red-Light Therapy in Myopia Control in Children: A Multicenter Randomized Controlled Trial
Abstract
PURPOSE
To assess the efficacy and safety of repeated low-level red-light (RLRL) therapy in myopia control in children.
DESIGN
Multicenter, randomized, parallel-group, single-blind clinical trial.
PARTICIPANTS
A total of 264 eligible children aged 8 to 13 years with myopia of cycloplegic spherical equivalent refraction (SER) of -1.00 to -5.00D, astigmatism 0.0 logMAR (Snellen 1.0 or 20/20) were enrolled in July to August 2019. Follow-up was completed in September 2020.
METHODS
Children were randomly assigned to the intervention group [RLRL treatment plus single vision spectacle (SVS)] and control group (SVS). The RLRL treatment was provided by a desktop light therapy device which emits red light of 650 nm in wavelength, at an illuminance level of approximately 1600 lux and a power of 0.29 mW for a 4-mm pupil (Class I Classification), and was administered at home under supervision of parents, 3 minutes per session, twice per day with a minimum interval of 4-hours, five days per week.
MAIN OUTCOME MEASURES
The primary outcome and a key secondary outcome were changes in axial length (AL) and SER measured at baseline, and 1-, 3-, 6- and 12-month follow-up visits. Participants who had at least one post-randomization follow-up visit were analyzed for treatment efficacy based on a longitudinal mixed model.
RESULTS
Among 264 randomized participants, 246 (93.2%) children were included in the analysis (n = 117 in the RLRL and n = 129 in the SVS group). Adjusted 12-month axial…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 264 participants or records.
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