Safety and Efficacy of Low-Dose Atropine with Orthokeratology in Pediatric Myopia

Overview

This two-year randomized clinical trial demonstrated that combining 0.01% atropine with orthokeratology lenses significantly slowed axial elongation in children with myopia compared to orthokeratology alone. The combination therapy was well tolerated, with minimal impact on ocular surface parameters and only a slight increase in pupillary light reflex latency.

Background

Myopia prevalence is rising globally, particularly in East Asia, posing risks for serious ocular complications due to axial elongation. Atropine eye drops and orthokeratology lenses are established interventions to slow myopia progression. Low-concentration atropine (0.01%) has shown efficacy with fewer side effects, and orthokeratology reshapes the cornea to reduce myopic progression. Combining these treatments may enhance myopia control, but long-term safety and efficacy data from rigorous trials have been limited.

Data Highlights

Key Findings

• The combination of 0.01% atropine and orthokeratology significantly reduced axial elongation over 24 months compared to orthokeratology alone (0.33 mm vs. 0.43 mm; p=0.004).
• Subgroup analyses showed greater efficacy in children aged 8–10 years and those with initial spherical equivalent refraction between −1.00 and −3.00D.
• No significant differences were observed between groups in tear meniscus height, non-invasive break-up time, visual acuity, or pupil size, indicating minimal ocular surface impact.
• The latency of the pupillary light reflex was significantly longer in the combination therapy group, suggesting a mild pharmacologic effect of atropine.
• The combination therapy was well tolerated with no reported serious adverse events related to ocular surface health.

Clinical Implications

Combining low-dose atropine with orthokeratology lenses offers an effective and safe strategy to slow myopia progression in children, particularly in younger patients and those with mild to moderate myopia. Clinicians can consider this combination to enhance myopia control without significant adverse effects on ocular surface health. Monitoring pupillary responses may be warranted due to atropine’s pharmacologic effects.

Conclusion

The study supports that 0.01% atropine combined with orthokeratology provides superior myopia control over two years with good safety and tolerability, representing a promising approach for managing pediatric myopia progression.

References

1. Clinical Trial Registration ChiCTR1800018419 -- Assessing the Safety and Effectiveness of Low-Concentration Atropine Combined with Orthokeratology