Purpose: The aim of this study was to assess the effect on myopia progression after cessation of topical atropine treatment.
Design: Parallel-group, placebo-controlled, randomized, double-masked study.
Participants: 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.