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Two-year outcomes of repeated red light therapy in premyopic children: sustained efficacy and rebound effects
Aim: To evaluate the 12-month efficacy and safety of repeated low-level red-light (RLRL) therapy combined with orthokeratology (ortho-k) (RCO) for controlling myopia in Spanish children. Methods: In this single-site, randomised, parallel-group, non-blinded clinical trial (NCT06899139), eligible myopic children aged 10-13 years were recruited and assigned randomly either to the RCO group or the ortho-k group. Follow-up assessments were conducted at 6, 9 and 12 months after baseline. The primary outcome and secondary outcome were the axial length (AL) and macular thickness (MT) changes at 12 months estimated by longitudinal mixed model. Results: All participants (n=26; 11 in the RCO group and 15 in the ortho-k group) were included in the analysis. After 12 months, the adjusted mean AL change was -0.124 mm (95% CI -0.164 to -0.084) in the RCO group, whereas the ortho-k group continued to exhibit a modest axial elongation of 0.102 mm (95% CI 0.068 to 0.136). The adjusted mean difference in AL change was -0.226 mm (95% CI -0.279 to -0.174) between the groups (p<0.001). 12="" the="" adjusted="" mean="" change="" in="" mt="" showed="" no="" significant="" difference="" between="" groups="" at="" months.="" rco="" of="" children="" achieved="" al="" shortening="">-0.05 mm, whereas no children in the ortho-k group showed AL shortening. No severe adverse events were reported during the study. Conclusions: Combining RLRL therapy with ortho-k is an effective and safe myopia control strategy in Caucasian Spanish children, supporting the potential generalisability of the synergistic effect across diverse ethnic groups.
