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Randomized Controlled Trial
. 2023 Mar;101(2):e177-e184.
doi: 10.1111/aos.15235. Epub 2022 Aug 23.

Myopia progression after cessation of low-dose atropine eyedrops treatment: A two-year randomized, double-masked, placebo-controlled, cross-over trial

Shifei Wei  1   2 , Shi-Ming Li  1   2 , Wenzai An  1   2 , Jialing Du  1   2 , Xintong Liang  1   2 , Yunyun Sun  1   2 , Jiahe Gan  1   2 , Weiling Bai  1   2 , Jiaxin Tian  1   2 , Zhining Cai  3 , Lei Yin  4 , Ningli Wang  1   2
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Free article
Randomized Controlled Trial

Myopia progression after cessation of low-dose atropine eyedrops treatment: A two-year randomized, double-masked, placebo-controlled, cross-over trial

Shifei Wei et al. Acta Ophthalmol. 2023 Mar.
Free article

Abstract

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.

Keywords: 0.01% atropine eye drops; axial elongation; myopia progression; rebound effect.

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References

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