October 1, 2025
By Nguyen Nguyen, MD, and Huy Tran, MD, PhD
Photo Credit: Getty Images
The underlying mechanism for myopia progression is uncertain. However, evidence supports the hypothesis that a lag of accommodation during near work can induce hyperopic defocus. This, in turn, triggers axial elongation.1 In intermittent exotropia (IXT), additional accommodative convergence is required to maintain binocular vision and ocular alignment. This might increase accommodative loads and potentially accelerate myopia progression.2
The relationship between IXT, accommodative function and myopia progression presents a clinical challenge, as these conditions frequently coexist. Therefore, it is crucial to manage myopia progression in children with IXT and exotropia in general. However, children with strabismus have been excluded from most previous myopia control trials involving atropine.
The study
This placebo-controlled, double-masked, randomized clinical trial aimed to investigate the efficacy and safety of 0.01% atropine eye drops compared to placebo drops of 1% hydroxypropyl methylcellulose on myopia progression in children with both myopia and intermittent exotropia. A total of 300 Chinese children aged 6–12 years with basic-type IXT and myopia ranging from −0.50D to −6.00D were enrolled and followed for 12 months. Participants were randomly assigned in a 2:1 ratio to 0.01% atropine or placebo eye drops administered in both eyes once at night. Primary outcomes included changes in cycloplegic spherical equivalent and axial length, with secondary analyses of accommodation, exodeviation and binocular vision parameters.
In summary, the study found that 0.01% atropine effectively slowed myopia progression and axial length elongation compared to placebo at 1 year with an annual mean difference between groups of 0.24D (95% CI from 0.11 to 0.37) for cycloplegic spherical equivalent refraction and -0.11 mm (95% CI from -0.17 to -0.06) for axial length. While accommodative amplitude decreased in the atropine group, there were no significant changes in best-corrected visual acuity or near vision. Furthermore, exotropia did not worsen, and binocular vision parameters remained stable throughout the study period.
The findings
These findings support the use of 0.01% atropine as an effective and safe intervention for myopia control in children with IXT, bridging an important gap in clinical knowledge for managing these co-existing conditions. Interestingly, previous research in general myopic populations has shown that 0.01% atropine efficacy in controlling spherical equivalent and axial length may be slightly greater in the second year compared to the first year, possibly due to a cumulative effect over time.3 Therefore, longer-term studies beyond 12 months are warranted to determine whether this pattern also applies to children with myopia and IXT.
Abstract
Importance
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.
DOI: 10.1001/jamaophthalmol.2024.2295
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Nguyen Nguyen, MD, is an ophthalmology resident at the University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam. Her clinical and research interests are in pediatric ophthalmology and myopia management. |
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Huy Tran, MD, PhD, is a lecturer at the University of Medicine and Pharmacy at Ho Chi Minh City. He is also the Head of the Myopia Control Clinic at Hai Yen Eye Care, Ho Chi Minh City, Vietnam. Dr. Tran collaborates with BHVI on myopia-related projects. Serving as the Asia-Pacific Ambassador for the International Myopia Institute, he actively contributes to shaping global strategies for myopia management. |
References
- Huang H-M, Chang DS-T, Wu P-C. The association between near work activities and myopia in children—a systematic review and meta-analysis. PloS one. 2015;10(10):e0140419.
- Ahn SJ, Yang HK, Hwang J-M. Binocular visual acuity in intermittent exotropia: role of accommodative convergence. American journal of ophthalmology. 2012;154(6):981-986. e3.
- Yam JC, Li FF, Zhang X, et al. Two-year clinical trial of the low-concentration atropine for myopia progression (LAMP) study: phase 2 report. Ophthalmology. 2020;127(7):910-919.
