https://mivision.com.au/2026/02/spanish-trial-confirms-rlrl-plus-ok-slow-myopia-progression/

Spanish Trial Confirms RLRL Plus OK Slow Myopia Progression

A landmark Spanish study1 has provided the strongest evidence to date of the efficacy of repeated low-level red-light (RLRL) in European children, and that its combination with orthokeratology (OK), in particular, offers substantially greater myopia control than OK alone. Published in the British Journal of Ophthalmology, the 12-month randomised controlled trial is the first fully Caucasian and European study of RLRL to be published, reinforcing findings of RLRL and OK combination therapy previously demonstrated only in East Asian populations.

The study was conducted at the Fernández-Velázquez Centre in Madrid and supported by devices from Eyerising International. It recruited 26 Caucasian Spanish children aged 10–13 years with myopia, randomly allocating them either to a RLRL plus OK group (RCO) or an OK group. The trial was a single-site, randomised, parallel-group, and non-blinded, with assessments performed at baseline and at six, nine, and 12 months. Children in the RCO group also underwent additional assessments at one and three months.

Significantly Slower Myopia Progression

Axial length (AL) change was the primary outcome, analysed using a longitudinal mixed model. At 12 months, the adjusted mean axial length change was -0.124 mm (95% CI -0.164 to -0.084) in the combination RCO group, representing significant axial shortening, while children wearing OK lenses alone showed continued eye growth of 0.102 mm (95% CI 0.068 to 0.136). This amounted to an adjusted mean difference of -0.226 mm (p < 0.001) between the groups. In practical terms, the combination therapy slowed axial elongation by approximately 0.215–0.226 mm more than OK alone over one year.

These findings mirror the results of previous East Asian studies, where RLRL has been shown to significantly reduce axial elongation, both independently and when combined with OK. In comparison, two studies in East Asia recruited poor responders to OK with continued myopia progression while on OK alone for one year, who were then randomised to either receive combination RCO or remain on OK alone. This Spanish study instead recruited treatment-naïve patients to begin RCO or OK. Similarly, all three studies reported axial shortening in the RCO group, an increasingly recognised phenomenon achieved with RLRL therapy. More than 80% of children in the RCO group achieved AL shortening greater than 0.05 mm, sustained to 12 months. No participants in the OK group exhibited any shortening.

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Safety and Tolerability

Safety outcomes were equally encouraging in this study. The adjusted mean change in macular thickness (MT), the study’s secondary endpoint, showed no significant differences between the two groups over the 12-month period. Optical coherence tomography (OCT) imaging revealed no structural concerns and no adverse events were reported.

Safety outcomes were equally encouraging in this study.

Treatment adherence was high, with a median compliance of 71% in the RLRL group. Interestingly, this was consistent with previously published RLRL trials in East Asia, demonstrating a similar adherence profile in Caucasian populations.

Broader Implications for Europe

The study holds significance for Western practitioners, as almost all published RLRL clinical data to date has involved East Asian children. Although RLRL therapy has now been available with strong real-world results thus far reported in other Western countries (e.g. Australia, New Zealand, United Kingdom, Norway), this would be the first 12-month study published demonstrating Caucasian treatment effect.

“This study demonstrated the synergistic effect of RLRL on OK in a European population, for which data had been limited,” the authors wrote. “Despite the satisfactory efficacy of OK in this cohort, adding RLRL therapy provided a significantly greater myopia control effect and slowed axial elongation by more than 0.2 mm annually compared to OK monotherapy, potentially lowering the long-term risk of vision-threatening complications such as myopic maculopathy.”

The researchers said the findings suggest that the biological mechanisms underpinning RLRL’s effect are not population-specific. “RLRL therapy with OK is an effective and safe myopia control strategy in Caucasian Spanish children,” the authors concluded, “supporting the potential generalisability of the synergistic effect across diverse ethnic groups.”

While the results are strong, the authors highlight that the study’s small sample size warrants larger, multi-centre trials across different European and multi-ethnic populations. Such studies would help clarify the consistency of treatment response, long-term durability of axial shortening, and the optimal integration of RLRL into European clinical pathways.

Reference

1. Fernández Fidalgo MJ, Ferigo Ferrel VD, Wu Y, et al. Repeated low-level red-light therapy combined with orthokeratology for myopia control in Spain: a randomised controlled study. British Journal of Ophthalmology Published Online First: 20 November 2025. doi: 10.1136/bjo-2025-328347.