Four hundred children aged 6 to 12 years with refractive error of spherical equivalent −1.00 to −6.00 diopters (D) and astigmatism of −1.50 D or less.
Intervention
No intervention was administered. Subjects were followed up for 12 months after stopping treatment, which consisted of either 1% atropine or vehicle eyedrops once nightly for 2 years. Only 1 eye of each subject was chosen through randomization for treatment.
Main Outcome Measures
The main efficacy outcome measures were change in spherical equivalent refraction as measured by cycloplegic autorefraction and change in ocular axial length as measured by ultrasonography.
Results
After cessation of atropine drops, the mean progression in the atropine-treated group was −1.14±0.80 D over 1 year, whereas the progression in placebo-treated eyes was −0.38±0.39 D (P<0.0001). However, after 3 years of participation in the trial (with 2 years on atropine treatment), eyes randomized to atropine have less severe myopia than other eyes. Spherical equivalent was −4.29±1.67 D in the atropine-treated eyes compared with −5.22±1.38 D in the placebo-treated eyes (P<0.0001). Spherical equivalents in atropine-untreated and placebo-untreated eyes were −5.00±1.62 D and −5.28±1.43 D, respectively. Over the 3 years, the increase in axial length of the atropine-treated eyes was 0.29±0.37 mm compared with 0.52±0.45 mm in the placebo-treated eyes (P<0.0001). After cessation of atropine, the amplitude of accommodation and near visual acuity returned to pretreatment levels.
Conclusions
After stopping treatment, eyes treated with atropine demonstrated higher rates of myopia progression compared with eyes treated with placebo. However, the absolute myopia progression after 3 years was significantly lower in the atropine group compared with placebo.
Financial Disclosure(s)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
ABSTRACT