October 3, 2022
By Dwight Akerman, OD, MBA, FAAO, FBCLA, FIACLE
Many eye care professionals have expressed concern about rebound after children and adolescents have applied topical low-dose atropine for myopia control. To address this concern, Wei, et al. conducted a randomized, double-masked, placebo-controlled, cross-over trial. The study aimed to evaluate myopia progression and axial elongation after stopping 0.01% atropine eye drops through a two-year cross-over study.
A total of 133 subjects completed two years of follow-up. In the first year, the mean myopia progression in the atropine-placebo group was 0.21 ± 0.08D slower than in the placebo-atropine group. After cross-over treatment, the mean myopia progression in the atropine-placebo group was 0.22 ± 0.07D faster than in the placebo-atropine group in the second year. Over two 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).
The researchers concluded that the difference in myopia progression between the atropine-placebo and placebo-atropine groups in Phase 1 was similar to Phase 2 during the cross-over treatment. This cross-over trial suggests no rebound effect after using 0.01% atropine eye drops to prevent myopia progression.
Abstract
Myopia Progression After Cessation of Low-Dose Atropine Eyedrops Treatment: A Two-Year Randomized, Double-Masked, Placebo-Controlled, Cross-Over Trial
Shifei Wei, Shi-Ming Li, Wenzai An, Jialing Du, Xintong Liang, Yunyun Sun, Jiahe Gan, Weiling Bai, Jiaxin Tian, Zhining Cai, Lei Yin, Ningli Wang
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 the analysis.
Results: One hundred thirty-three subjects completed 2 years of follow-up. In the first year, the mean myopia progression in the atropine-placebo group was 0.21 ± 0.08 D slower than in the placebo-atropine group. After cross-over treatment, the mean myopia progression in the atropine-placebo group was 0.22 ± 0.07D faster than in the 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 the progression of myopia.
Wei, S., Li, S. M., An, W., Du, J., Liang, X., Sun, Y., … & Wang, N. (2022). Myopia progression after cessation of low‐dose atropine eyedrops treatment: A two‐year randomized, double‐masked, placebo‐controlled, cross‐over trial. Acta Ophthalmologica.
DOI: https://doi.org/10.1111/aos.15235
