A study involving Caucasian Spanish children has found that combining RLRL therapy with ortho-k is an effective and safe myopia control strategy, slowing myopia control significantly more than ortho-k alone.
The study, led by the Fernández-Velázquez Centre in Madrid and supported by devices from Eyerising International, tracked 26 children in a single-site, randomised, parallel-group, non-blinded clinical trial.
It involved eligible myopic children aged 10–13 years, who were assigned randomly either to a group using repeated low-level red-light (RLRL) therapy combined with orthokeratology (RCO) or an ortho-k group.
Follow-up assessments were conducted at 1, 3, 6, 9 and 12 months after baseline for the RCO group and 6, 9 and 12 months for the ortho-k group.
Researchers reported that RCO significantly slowed the axial elongation over 12 months compared with ortho-k alone.
After 12 months, the adjusted mean axial length (AL) change was −0.111 mm in the RCO group, whereas the ortho-k group continued to exhibit a modest axial elongation of 0.104 mm.
Also, they observed significant AL shortening among participants in the RLRL group, with over 80% achieving shortening of >0.05mm sustained to 12 months, with none reported in the ortho-k group.
No significant macular thickening (MT) was observed during the combination therapy period, and no adverse events were reported or structural damage noted from OCT analysis.
“This study demonstrated the synergistic effect of RLRL on ortho-k in a European population, for which data had been limited,” the authors said.
“Despite the satisfactory efficacy of ortho-k in this cohort, adding RLRL therapy to ortho-k provided a significantly greater myopia control effect and slowed the axial elongation by 0.215 mm annually more than ortho-k monotherapy, potentially lowering the long- term risk of vision-threatening complications such as myopic maculopathy.”
Although RLRL’s treatment effect in an East Asian population has been extensively demonstrated, including in combination with ortho-k, this is the first study to report RLRL’s 12-month treatment response in a Caucasian and European population.
The authors noted these results aligned with the findings observed in East Asia, further supporting the efficacy and safety of RCO as a broadly applicable myopia control approach across populations with different racial backgrounds.
However, given the small sample size of this study, further multi-ethnic research was warranted.
