Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study

Purpose Atropine eye drops prevent the progression of myopia, but their use has not been tested in the Japanese schoolchildren population. Here, we evaluate the efficacy and safety of 0.01% atropine eye drops for myopia control in Japanese children. Study design Multicenter (7 university hospitals),...

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Bibliographic Details
Published in:Japanese journal of ophthalmology 2021-05, Vol.65 (3), p.315-325
Main Authors: Hieda, Osamu, Hiraoka, Takahiro, Fujikado, Takashi, Ishiko, Satoshi, Hasebe, Satoshi, Torii, Hidemasa, Takahashi, Hiroshi, Nakamura, Yo, Sotozono, Chie, Oshika, Tetsuro, Morimoto, Takeshi, Nishida, Kohji, Nishikawa, Noriko, Song, Young-Seok, Tokutake, Tomoki, Nishi, Yasuyo, Shigeno, Yuta, Kurihara, Toshihide, Negishi, Kazuno, Tsubota, Kazuo, Ono, Masafumi, Nakai, Tomoko, Tan, Donald, Tanaka, Shiro, Kinoshita, Shigeru
Format: Article
Language:English
Subjects:
Astigmatism
Atropine
Children
Clinical Investigation
Confidence intervals
Conjunctivitis
Hay fever
Medicine
Medicine & Public Health
Myopia
Ophthalmology
Placebos
Safety
Side effects
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Summary:Purpose Atropine eye drops prevent the progression of myopia, but their use has not been tested in the Japanese schoolchildren population. Here, we evaluate the efficacy and safety of 0.01% atropine eye drops for myopia control in Japanese children. Study design Multicenter (7 university hospitals), randomized, double-masked, placebo-controlled trial. Methods Participants were 171 Japanese schoolchildren aged 6 to 12 years, with progressive myopia, spherical equivalence (SE) of −1.00 to −6.00 diopters (D), and astigmatism of ≤1.5 D. They were randomized to receive either 0.01% atropine ( n =85) or placebo ( n =86) eye drops once nightly OU for 24 months. Primary and secondary efficacy endpoints were changes in SE and axial length (AL), respectively, from baseline to month 24. Results Data from 168 subjects were analyzed. At month 24, compliance was similar in both groups (atropine: 83.3%; placebo: 85.7%). The least squares mean change in SE and AL from baseline were, respectively, −1.26 D (95% confidence interval [CI]: −1.35, −1.17) and 0.63 mm (0.59, 0.67) for atropine and −1.48 D (− 1.57, −1.39) and 0.77 mm (0.73, 0.81) for placebo. Inter-group differences were 0.22 D (95% CI: 0.09, 0.35; P  
ISSN:0021-5155
1613-2246
DOI:10.1007/s10384-021-00822-y