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Purpose <p>It remains unclear whether increasing the frequency of administration of 0.01% atropine improves its effectiveness in slowing axial elongation or refractive progression. This study compared twice-daily 0.01% atropine administration and traditional once-nightly administration.</p> Methods <p>A hybrid design was adopted incorporating both retrospective and prospective elements, with participants observed for 1 year. The control group (received saline eye drops) and once-daily 0.01% atropine group (Atropine-1 group) were derived from two previous trials, while the twice-daily 0.01% atropine group (Atropine-2 group) was enrolled prospectively. A total of 163 participants were included in the intention-to-treat set, with 51, 70 and 42 participants in the control, Atropine-1 and Atropine-2 groups, respectively. The primary outcome was the change in axial length (AL), and the secondary outcome was the change in cycloplegic spherical equivalent refraction (SER).</p> Results <p>Compared with the control group (0.48 ± 0.22 mm), both Atropine-1 (0.26 ± 0.17 mm) and Atropine-2 (0.15 ± 0.18 mm) groups showed significantly reduced AL elongation (<i>p &lt;</i> 0.001). Notably, Atropine-2 significantly improved slowing of AL elongation compared with Atropine-1 (<i>p =</i> 0.008). The result of the secondary outcome (adjusted SER change) was consistent. Atropine-2 was significantly more effective in slowing SER progression (−0.15 ± 0.37 D) than Atropine-1 (−0.41 ± 0.50 D) (<i>p =</i> 0.02). Based on a multivariable model, age was identified as the key covariate to perform subgroup analyses. In the younger subgroup (8–10 years), AL elongation was significantly reduced in the Atropine-2 group (0.16 ± 0.17 mm) compared with the Atropine-1 group (0.36 ± 0.22 mm; <i>p =</i> 0.002). In the older subgroup (10–12 years), there was no significant difference in progression. Consistent results were observed in the sensitivity analyses based on the per-protocol set.</p> Conclusion <p>Twice-daily administration of 0.01% atropine was more effective than once daily in slowing AL elongation and SER progression in children 8 to 10 years of age. Further investigation with extended follow-up is warranted to substantiate this finding.</p>

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Twice-daily administration improves the effectiveness of 0.01% atropine for controlling myopia in slowing axial elongation and refractive progression

  • 期刊论文

  • 发表日期：

    2025年7月23日

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  • Shengsong Xu,
  • Mengyi Wang,
  • Yiwen Qu,
  • Yanbin Wang,
  • Jinyun Jiang,
  • Fengqi Zhou,
  • Wenchen Zhao,
  • Bingru Zheng,
  • Weiyin Chen,
  • Xingyu Lei,
  • Zhouyue Li,
  • Yin Hu,
  • Xiao Yang

摘要

Purpose

It remains unclear whether increasing the frequency of administration of 0.01% atropine improves its effectiveness in slowing axial elongation or refractive progression. This study compared twice-daily 0.01% atropine administration and traditional once-nightly administration.

Methods

A hybrid design was adopted incorporating both retrospective and prospective elements, with participants observed for 1 year. The control group (received saline eye drops) and once-daily 0.01% atropine group (Atropine-1 group) were derived from two previous trials, while the twice-daily 0.01% atropine group (Atropine-2 group) was enrolled prospectively. A total of 163 participants were included in the intention-to-treat set, with 51, 70 and 42 participants in the control, Atropine-1 and Atropine-2 groups, respectively. The primary outcome was the change in axial length (AL), and the secondary outcome was the change in cycloplegic spherical equivalent refraction (SER).

Results

Compared with the control group (0.48 ± 0.22 mm), both Atropine-1 (0.26 ± 0.17 mm) and Atropine-2 (0.15 ± 0.18 mm) groups showed significantly reduced AL elongation (p < 0.001). Notably, Atropine-2 significantly improved slowing of AL elongation compared with Atropine-1 (p = 0.008). The result of the secondary outcome (adjusted SER change) was consistent. Atropine-2 was significantly more effective in slowing SER progression (−0.15 ± 0.37 D) than Atropine-1 (−0.41 ± 0.50 D) (p = 0.02). Based on a multivariable model, age was identified as the key covariate to perform subgroup analyses. In the younger subgroup (8–10 years), AL elongation was significantly reduced in the Atropine-2 group (0.16 ± 0.17 mm) compared with the Atropine-1 group (0.36 ± 0.22 mm; p = 0.002). In the older subgroup (10–12 years), there was no significant difference in progression. Consistent results were observed in the sensitivity analyses based on the per-protocol set.

Conclusion

Twice-daily administration of 0.01% atropine was more effective than once daily in slowing AL elongation and SER progression in children 8 to 10 years of age. Further investigation with extended follow-up is warranted to substantiate this finding.