Osamu Hieda1, Takahiro Hiraoka2, Takashi Fujikado3, Satoshi Ishiko4, Satoshi Hasebe5, Hidemasa Torii6, Hiroshi Takahashi7, Yo Nakamura1, Chie Sotozono1, Tetsuro Oshika2, Takeshi Morimoto8, Kohji Nishida9, Noriko Nishikawa4, Young-Seok Song4, Tomoki Tokutake10, Yasuyo Nishi6, Yuta Shigeno6, Toshihide Kurihara6, Kazuno Negishi6, Kazuo Tsubota6,11, Masafumi Ono7, Tomoko Nakai12, Donald Tan13, Shiro Tanaka12, Shigeru Kinoshita14. 1. Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Kyoto, Japan. 2. Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Tusukuba, Ibaraki, Japan. 3. Graduate School of Frontier Biosciences, Osaka University, Suita, Osaka, Japan. 4. Department of Ophthalmology, Asahikawa Medical University, Asahikawa, Hokkaido, Japan. 5. Department of Ophthalmology 2, Kawasaki Medical School, Kurashiki, Okayama, Japan. 6. Department of Ophthalmology, Keio University School of Medicine, Shinjuku-ku, Tokyo, Japan. 7. Department of Ophthalmology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan. 8. Department of Advanced Visual Neuroscience, Osaka University Graduate School of Medicine, Suita, Osaka, Japan. 9. Department of Ophthalmology, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan. 10. Department of Ophthalmology, Kawasaki Medical School General Medical Center, Okayama, Okayama, Japan. 11. Tsubota Laboratory, Inc, Shinjuku-ku, Tokyo, Japan. 12. Clinical Biostatistics Course, School of Public Health, Graduate School of Medicine, Kyoto University, Kyoto, Kyoto, Japan. 13. Singapore National Eye Centre, Singapore, Singapore. 14. Department of Frontier Medical Science and Technology for Ophthalmology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kamigyo-ku, Kyoto, Kyoto, 602-0841, Japan. shigeruk@koto.kpu-m.ac.jp.
Abstract
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 < 0.001) for SE and - 0.14 mm (-0.20, -0.08; P < 0.001) for AL. Three patients experienced mild allergic conjunctivitis side effects, with no inter-group difference in incidence (atropine: 2.4%; 2/84 patients; placebo: 1.4%; 1/84 patients). CONCLUSION: With good compliance, 0.01% atropine is effective and safe for preventing the progression of childhood myopia.
RCT Entities:
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 < 0.001) for SE and - 0.14 mm (-0.20, -0.08; P < 0.001) for AL. Three patients experienced mild allergic conjunctivitis side effects, with no inter-group difference in incidence (atropine: 2.4%; 2/84 patients; placebo: 1.4%; 1/84 patients). CONCLUSION: With good compliance, 0.01% atropine is effective and safe for preventing the progression of childhood myopia.
Entities:
Keywords:
Eye drop; Muscarinic receptor; Myopia control; Placebo; School children