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Outcomes of 0.01% Atropine Eye Drop Therapy in Children With Myopia and Intermittent Exotropia
TAKE-HOME MESSAGE
- In this study, the authors presented the 1-year primary outcomes in children with myopia and intermittent exotropia treated with topical 0.01% atropine. Overall, treatment with atropine resulted in less myopia progression at 1 year (−0.51 D vs −0.75 D; P < .001), with a lower proportion of eyes progressing to ≥1 D of myopia (19.3% vs 36.2%). The near magnitude of exotropia deviation decreased significantly in patients receiving atropine therapy (−1.25 PD versus 0.74 PD; P = .03); however, the amplitude of accommodation was significantly decreased (−3.06 D vs 0.12 D). Atropine therapy did not have a significant effect on binocular visual function, and no significant adverse effects were reported.
- Atropine may slow myopia progression in children with intermittent exotropia without having an adverse effect on binocular visual function.
abstract
This abstract is available on the publisher's site.
Access this abstract nowIMPORTANCE
Exotropia and myopia are commonly coexistent. However, evidence is limited regarding atropine interventions for myopia control in children with myopia and intermittent exotropia (IXT).
OBJECTIVE
To 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 PARTICIPANTS
This 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.
INTERVENTION
Participants 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 MEASURES
The 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.
RESULTS
Among 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 RELEVANCE
The 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 REGISTRATION
Chinese Clinical Trial Registry Identifier: ChiCTR2000039827.
Additional Info
Disclosure statements are available on the authors' profiles:
0.01% Atropine Eye Drops in Children With Myopia and Intermittent Exotropia: The AMIXT Randomized Clinical Trial
JAMA Ophthalmol 2024 Aug 01;142(8)722-730, Z Wang, T Li, X Zuo, T Zhang, L Liu, C Zhou, Z Leng, X Chen, L Wang, X Wang, H LiuFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
This is an important clinical topic, as the use of 0.01% atropine has yielded mixed results in terms of providing clinically significant control of myopia progression in children. The topic takes on added significance because there is a school of thought that children with intermittent exotropia (IXT) may be more prone to progressive myopia if they continuously use accommodative convergence through the accommodative convergence/accommodation mechanism to compensate for poor fusional convergence. This has also been the subject of study in the context of overminus lens therapy as a potential treatment for IXT.
In the same issue of this journal, there is an invited commentary by Dr. Jonathan Holmes on this paper titled "Evaluating Baseline Data in Clinical Trials — Can I Apply the Results?"1 He expressed concern about the extent of IXT control among the participants in this study. The authors have replied to the commentary, stating: "We are conducting a new clinical trial to compare the efficacy and safety of 0.01%, 0.02%, and 0.04% atropine eye drops in children with myopia and IXT. We hope to validate the control score finding and the effect of 0.01% atropine on IXT in this trial."
Reference