Objective To systematically evaluate the efficacy and safety of low-concentration atropine eye drops combined with orthokeratology for myopia control in children and adolescents.

Methods CNKI, WanFang Data, Web of Science, PubMed, Cochrane Library, and Embase were searched from inception to January 2026 for randomized controlled trials comparing low-concentration atropine plus orthokeratology with orthokeratology alone. Two reviewers independently screened studies, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 1.0 (RoB 1.0) tool. Meta-analysis was performed using RevMan 5.4 and R 4.4.2.

Results A total of 20 studies involving 1,750 participants were included. Meta-analysis results showed that, compared with orthokeratology alone, the combination of low-concentration atropine eye drops and orthokeratology tended to reduce the axial length, but the difference was not statistically significant [MD=-0.29 mm, 95%CI (-0.60, 0.01)]; significantly delayed the progression of spherical equivalent [MD=0.19 D, 95%CI (0.12, 0.26)]; and significantly increased the pupil diameter [MD=0.52 mm, 95%CI (0.26, 0.78)]; there was no statistically significant difference in the incidence of adverse events between the two groups [RR=0.95, 95%CI (0.72, 1.26)].

Conclusion Current evidence suggests that low-concentration atropine eye drops combined with orthokeratology are superior to orthokeratology alone in controlling spherical equivalent, but no significant benefit was observed in delaying axial length increase, and the combination therapy did not significantly increase the overall incidence of adverse events. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusion.

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