One-year changes in axial length and refraction in children using low-level red light and distant-image screen for myopia control: a randomized controlled trial.

Objective: To assess the efficacy and safety of 650-nm low-level red light (RL) and distant-image therapy (DIT) for myopia. Methods: A randomized clinical trial. Children aged 8-10 years with a spherical equivalent error (SER) ranging from -1 to -1.5 diopters (D) were enrolled, and were randomly allocated to the following group: RL, DIT, RL + DIT, and control in a 1:1:1:1 ratio. The primary outcomes were changes in SER and axial length (AL). Results: One hundred and sixteen children randomized, girls accounted for 45.69% (53/116). The median one-year changes in SER were 0.21D (inter-quartile range, IQR: -0.03D to 0.46D), -0.06D (-0.32D to 0.19D), -0.08D (-0.31D to 0.14D), and -0.30D (-0.51D to -0.09D), respectively, for the RL + DIT, RL, DIT, and the control group. The median one-year changes in AL were 0.04 mm (-0.03 mm to 0.13 mm), 0.05 mm (-0.03 mm to 0.14 mm), 0.30 mm (0.22 mm to 0.37 mm), and 0.42 mm (0.35 mm to 0.49 mm), respectively, for the RL + DIT, RL, DIT, and the control group. Fundus photographs revealed no retinal changes across all groups. Conclusion: Participants who underwent daily 650-nm low-level red light therapy combined with distant-image screen intervention for 12 months demonstrated a significant deceleration in myopia progression, with 79.3% exhibiting potential for reversal of myopia. No safety concerns were identified through OCT and fundus photography. Clinical trial registration: ClinicalTrials.gov, NCT06683287.