Myopia is the most common ocular disorder among both children and adults, especially in children.[1–5] It is often associated with an increased risk of chorioretinal degeneration, retinal detachment, and other vision-threatening issues.[6–9] It was reported that approximately 27% of children in the primary school had myopia, and this figure increased to 73% in high school.[10,11] Presently, it has become a severe public health problem among the pediatric population worldwide. Thus, effective therapies are urgently needed to halt its progression and reduce the burden of refractive error.

Although it has been reported that pirenzepine gel,[12] contact lenses,[13–15] increased sunlight exposure, and outdoor activity[16–18] can decrease or even stop the progression, the results of their efficacies are disappointing. According to previous studies, atropine appeared promising in decreasing the rate of myopic progression.[19–21] However, its effects varied among the studies because of the different concentrations of atropine used.

In this study, we aimed to explore the efficacy and safety of atropine 0.5% eyedrops (ATE) for the treatment of children with low myopia (LM). We hypothesized that for treatment of children with LM, the effect of 0.5% ATE would be superior to the effect of placebo.

This clinical trial was approved by the ethics committee of The People's Hospital of Yan’an and was conducted at The People's Hospital of Yan’an and Affiliated Hospital of Yan’an Medical University from January 2014 to December 2016. One hundred twenty-six eligible children were randomly divided into an intervention group or a control group at a ratio of 1:1. Participants in the intervention group received 0.5% ATE, while those in the control group received placebo. Participants in both groups were administered eye drops once daily at night for a total duration of 1 year.

In this study, all participants met the following inclusion criteria: diagnosis of LM, defined as a spherical equivalent (SE) ranging from -0.50 to −2.00 diopters (D), as measured by cycloplegic autorefraction; age between 5 and 10 years; normal intraocular pressure (IOP;