Randomized double-blind trial finds nightly low-dose atropine does not slow myopia progression in US children, indicating this treatment lacks efficacy in this population.
Key Points
To evaluate the efficacy of low-dose 0.01% atropine eye drops compared with placebo for slowing myopia progression and axial elongation in US children.
Randomized, double-masked, placebo-controlled clinical trial (NCT03334253) conducted across 12 US sites involving 187 children aged 5 to 12 years with low to moderate bilateral myopia (-1.00 D to -6.00 D).
Participants were randomly assigned 2:1 to receive nightly 0.01% atropine eye drops (n = 125) or placebo (n = 62) for 24 months, followed by 6 months of off-treatment observation.
Automated cycloplegic refraction and axial length were assessed by masked examiners at baseline, 24 months, and 30 months.
At 24 months, adjusted mean change in spherical equivalent refractive error was -0.82 D (95% CI, -0.96 to -0.68 D) in the atropine group versus -0.80 D (95% CI, -0.98 to -0.62 D) in the placebo group (adjusted difference: -0.02 D; 95% CI, -0.19 to +0.15 D; P = .83).
Adjusted mean change in axial length from baseline to 24 months was 0.44 mm (95% CI, 0.39 to 0.50 mm) for atropine versus 0.45 mm (95% CI, 0.37 to 0.52 mm) for placebo (adjusted difference: -0.002 mm; 95% CI, -0.106 to 0.102 mm).
At 30 months, adjusted differences remained nonsignificant between atropine and placebo for refractive error change (-0.04 D; 95% CI, -0.25 to +0.17 D) and axial elongation (+0.009 mm; 95% CI, -0.115 to 0.134 mm).