IMPORTANCEBecause studies have suggested that atropine might slow the progression of myopia in children, randomized clinical trials are warranted to understand this potential causal relationship.OBJECTIVE To evaluate the efficacy and safety of atropine, 0.01%, eyedrops on slowing myopia progression and axial elongation in Chinese children. DESIGN, SETTING, AND PARTICIPANTSThis was a randomized, placebo-controlled, double-masked study. A total of 220 children aged 6 to 12 years with myopia of −1.00 D to −6.00 D in both eyes were enrolled between April 2018 and July 2018 at Beijing Tongren Hospital, Beijing, China. Cycloplegic refraction and axial length were measured at baseline, 6 months, and 12 months. Adverse events were also recorded.INTERVENTIONS Patients were randomly assigned in a 1:1 ratio to atropine, 0.01%, or placebo groups to be administered once nightly to both eyes for 1 year.MAIN OUTCOMES AND MEASURES Mean changes and percentage differences in myopia progression and axial elongation between atropine, 0.01%, or placebo groups. RESULTSOf 220 participants, 103 were girls (46.8%), and the mean (SD) age was 9.64 (1.68) years. The mean (SD) baseline refractive error and axial length were -2.58 (1.39) D and 24.59 (0.87) mm. Follow-up at 1 year included 76 children (69%) and 83 children (75%) allocated into the atropine, 0.01%, and placebo groups, respectively, when mean myopia progression was −0.49 (0.42) D and −0.76 (0.50) D in the atropine, 0.01%, and placebo groups (mean difference, 0.26 D; 95% CI, 0.12-0.41 D; P < .001), with a relative reduction of 34.2% in myopia progression. The mean (SD) axial elongation in the atropine, 0.01%, group was 0.32 (0.19) mm compared with 0.41 (0.19) mm in the placebo group (mean difference, 0.09 mm; 95% CI, 0.03-0.15 mm; P = .004), with relative reduction of 22.0% in axial elongation. Fifty-one percent and 13.2% of children progressed by at least 0.50 D and 1.00 D in the atropine, 0.01%, group, compared with 69.9% and 34.9% in the placebo group. No serious adverse events related to atropine were reported.CONCLUSIONS AND RELEVANCE While the clinical relevance of the results cannot be determined from this trial, these 1-year results, limited by approximately 70% follow-up, suggest that atropine, 0.01%, eyedrops can slow myopia progression and axial elongation in children and warrant future studies to determine longer-term results and potential effects on slowing sight-threatening pathologic changes later in life.

Purpose The purpose of the study was to evaluate myopia progression and axial elongation after stopping 0.01% atropine eye drops through a 2‐year cross‐over study. Methods This study was a randomized, double‐masked, placebo‐controlled, cross‐over trial in mainland China. 220 children aged 6–12 years with spherical equivalent range of −1.00 D to −6.00 D in both eyes were enrolled in Phase 1 for 1 year. Children who had completed the first year's follow‐up continued in the second phase. In Phase 2, the placebo group was crossed over to the 0.01% atropine group (referred to as the ‘placebo‐atropine group’), and the 0.01% atropine group was crossed over to the placebo group (referred to as the ‘atropine‐placebo group’). All children underwent the examination of cycloplegic refraction and axial length at a 6‐month interval. Only data from right eyes were included in analysis. Results One hundred thirty‐three subjects completed 2 years of follow‐up. In the first year, the mean myopia progression in atropine‐placebo group was 0.21 ± 0.08 D slower than that in placebo‐atropine group. After cross‐over treatment, the mean myopia progression in atropine‐placebo group was 0.22 ± 0.07D faster than that in placebo‐atropine group in the second year. Over 2 years, the mean myopia progression was −1.26 ± 0.66D and −1.25 ± 0.70D in the atropine‐placebo and placebo‐atropine groups (p = 0.954). Conclusions The difference in myopia progression between atropine‐placebo group and placebo‐atropine group in Phase 1 was similar to Phase 2 during the cross‐over treatment. Through our cross‐over trial, the results suggest that there is no rebound effect after using 0.01% atropine eye drops to prevent progression of myopia.

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