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. 2024 Jan 1;142(1):15-23.
doi: 10.1001/jamaophthalmol.2023.5467.

Topical Atropine for Childhood Myopia Control: The Atropine Treatment Long-Term Assessment Study

Yong Li  1   2 , Michelle Yip  1 , Yilin Ning  2 , Joey Chung  1 , Angeline Toh  1 , Cheryl Leow  1 , Nan Liu  2 , Daniel Ting  1   2 , Leopold Schmetterer  1   2   3   4   5   6   7 , Seang-Mei Saw  1   2   8 , Jost B Jonas  1   7   9 , Audrey Chia  1   2 , Marcus Ang  1   2
Affiliations

Topical Atropine for Childhood Myopia Control: The Atropine Treatment Long-Term Assessment Study

Yong Li et al. JAMA Ophthalmol. .

Abstract

Importance: Clinical trial results of topical atropine eye drops for childhood myopia control have shown inconsistent outcomes across short-term studies, with little long-term safety or other outcomes reported.

Objective: To report the long-term safety and outcomes of topical atropine for childhood myopia control.

Design, setting, and participants: This prospective, double-masked observational study of the Atropine for the Treatment of Myopia (ATOM) 1 and ATOM2 randomized clinical trials took place at 2 single centers and included adults reviewed in 2021 through 2022 from the ATOM1 study (atropine 1% vs placebo; 1999 through 2003) and the ATOM2 study (atropine 0.01% vs 0.1% vs 0.5%; 2006 through 2012).

Main outcome measures: Change in cycloplegic spherical equivalent (SE) with axial length (AL); incidence of ocular complications.

Results: Among the original 400 participants in each original cohort, the study team evaluated 71 of 400 ATOM1 adult participants (17.8% of original cohort; study age, mean [SD] 30.5 [1.2] years; 40.6% female) and 158 of 400 ATOM2 adult participants (39.5% of original cohort; study age, mean [SD], 24.5 [1.5] years; 42.9% female) whose baseline characteristics (SE and AL) were representative of the original cohort. In this study, evaluating ATOM1 participants, the mean (SD) SE and AL were -5.20 (2.46) diopters (D), 25.87 (1.23) mm and -6.00 (1.63) D, 25.90 (1.21) mm in the 1% atropine-treated and placebo groups, respectively (difference of SE, 0.80 D; 95% CI, -0.25 to 1.85 D; P = .13; difference of AL, -0.03 mm; 95% CI, -0.65 to 0.58 mm; P = .92). In ATOM2 participants, the mean (SD) SE and AL was -6.40 (2.21) D; 26.25 (1.34) mm; -6.81 (1.92) D, 26.28 (0.99) mm; and -7.19 (2.87) D, 26.31 (1.31) mm in the 0.01%, 0.1%, and 0.5% atropine groups, respectively. There was no difference in the 20-year incidence of cataract/lens opacities, myopic macular degeneration, or parapapillary atrophy (β/γ zone) comparing the 1% atropine-treated group vs the placebo group.

Conclusions and relevance: Among approximately one-quarter of the original participants, use of short-term topical atropine eye drops ranging from 0.01% to 1.0% for a duration of 2 to 4 years during childhood was not associated with differences in final refractive errors 10 to 20 years after treatment. There was no increased incidence of treatment or myopia-related ocular complications in the 1% atropine-treated group vs the placebo group. These findings may affect the design of future clinical trials, as further studies are required to investigate the duration and concentration of atropine for childhood myopia control.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ting reported grants from the National Medical Research Council, Singapore, Agency for Science, Technology and Research, and Duke-NUS Medical School during the conduct of the study; in addition, Dr Ting had a patent for a deep-learning system for the detection of retinal diseases issued. Dr Jonas reported a patent for European patent EP 3 271 392, JP 2021-119187, and US 2021 0340237 A1 (agents for use in the therapeutic or prophylactic treatment of myopia or hyperopia). Dr Chia reported Royalties from Myopine. No other disclosures were reported.

Figures

Figure.
Figure.. Timeline of the Atropine Treatment Long-Term Assessment Study
ATOM indicates Atropine for the Treatment of Myopia.
See this image and copyright information in PMC

Comment in

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