0.01% Atropine Eye Drops in Children With Myopia and Intermittent Exotropia

Abstract

ImportanceExotropia and myopia are commonly coexistent. However, evidence is limited regarding atropine interventions for myopia control in children with myopia and intermittent exotropia (IXT).ObjectiveTo evaluate the efficacy and safety of 0.01% atropine eye drops on myopia progression, exotropia conditions, and binocular vision in individuals with myopia and IXT.Design, Setting, and ParticipantsThis placebo-controlled, double-masked, randomized clinical trial was conducted from December 2020 to September 2023. Children aged 6 to 12 years with basic-type IXT and myopia of −0.50 to −6.00 diopters (D) after cycloplegic refraction in both eyes were enrolled.InterventionParticipants were randomly assigned in a 2:1 ratio to 0.01% atropine or placebo eye drops administered in both eyes once at night for 12 months.Main Outcomes and MeasuresThe primary outcome was change in cycloplegic spherical equivalent from baseline at 1 year. Secondary outcomes included change in axial length (AL), accommodative amplitude (AA), exotropia conditions, and binocular vision at 1 year.ResultsAmong 323 screened participants, 300 children (mean [SD] age, 9.1 [1.6] years; 152 male [50.7%]) were included in this study. A total of 200 children (66.7%) were in the atropine group, and 100 (33.3%) were in the placebo group. At 1 year, the 0.01% atropine group had slower spherical equivalent progression (−0.51 D vs −0.75 D; difference = 0.24 D; 95% CI, 0.11-0.37 D; P < .001) and AL elongation (0.31 mm vs 0.42 mm; difference = −0.11 mm; 95% CI, −0.17 to −0.06 mm; P < .001) than the placebo group. The mean AA change was −3.06 D vs 0.12 D (difference = −3.18 D; 95% CI, −3.92 to −2.44 D; P < .001) in the atropine and placebo groups, respectively. The 0.01% atropine group had a decrease in near magnitude of exodeviation whereas the placebo group had an increase (−1.25 prism diopters [PD] vs 0.74 PD; difference = −1.99 PD; 95% CI, −3.79 to −0.19 PD; P = .03). In the atropine vs placebo group, respectively, the incidence of study drug-related photophobia was 6.0% (12 of 200 participants) vs 8.0% (8 of 100 participants; difference = −2.0%; 95% CI, −9.4% to 3.7%; P = .51) and for blurred near vision was 6.0% (12 of 200 participants) vs 7.0% (7 of 100 participants) (difference = −1.0%; 95% CI, −8.2% to 4.5%; P = .74).Conclusions and RelevanceThe findings of this randomized clinical trial support use of 0.01% atropine eye drops, although compromising AA to some extent, for slowing myopia progression without interfering with exotropia conditions or binocular vision in children with myopia and IXT.Trial RegistrationChinese Clinical Trial Registry Identifier: ChiCTR2000039827