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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Veröffentlicht in:Japanese journal of ophthalmology 2021-05, Vol.65 (3), p.315-325
Hauptverfasser: 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
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container_title Japanese journal of ophthalmology
container_volume 65
creator 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
description 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  
doi_str_mv 10.1007/s10384-021-00822-y
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Study Group ; the ATOM-J. Study Group</creatorcontrib><description>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  &lt; 0.001) for SE and − 0.14 mm (−0.20, −0.08; P  &lt; 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.</description><identifier>ISSN: 0021-5155</identifier><identifier>EISSN: 1613-2246</identifier><identifier>DOI: 10.1007/s10384-021-00822-y</identifier><identifier>PMID: 33586090</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Astigmatism ; Atropine ; Childhood ; Children ; Clinical Investigation ; Confidence intervals ; Conjunctivitis ; Hay fever ; Medicine ; Medicine &amp; Public Health ; Myopia ; Ophthalmology ; Placebos ; Safety ; Side effects</subject><ispartof>Japanese journal of ophthalmology, 2021-05, Vol.65 (3), p.315-325</ispartof><rights>Japanese Ophthalmological Society 2021</rights><rights>Japanese Ophthalmological Society 2021.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c492t-33730d4f0c2f6ad453ab58611e71849958cc5fd2664080bfdf69bedf093a78ba3</citedby><cites>FETCH-LOGICAL-c492t-33730d4f0c2f6ad453ab58611e71849958cc5fd2664080bfdf69bedf093a78ba3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10384-021-00822-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10384-021-00822-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33586090$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hieda, Osamu</creatorcontrib><creatorcontrib>Hiraoka, Takahiro</creatorcontrib><creatorcontrib>Fujikado, Takashi</creatorcontrib><creatorcontrib>Ishiko, Satoshi</creatorcontrib><creatorcontrib>Hasebe, Satoshi</creatorcontrib><creatorcontrib>Torii, Hidemasa</creatorcontrib><creatorcontrib>Takahashi, Hiroshi</creatorcontrib><creatorcontrib>Nakamura, Yo</creatorcontrib><creatorcontrib>Sotozono, Chie</creatorcontrib><creatorcontrib>Oshika, Tetsuro</creatorcontrib><creatorcontrib>Morimoto, Takeshi</creatorcontrib><creatorcontrib>Nishida, Kohji</creatorcontrib><creatorcontrib>Nishikawa, Noriko</creatorcontrib><creatorcontrib>Song, Young-Seok</creatorcontrib><creatorcontrib>Tokutake, Tomoki</creatorcontrib><creatorcontrib>Nishi, Yasuyo</creatorcontrib><creatorcontrib>Shigeno, Yuta</creatorcontrib><creatorcontrib>Kurihara, Toshihide</creatorcontrib><creatorcontrib>Negishi, Kazuno</creatorcontrib><creatorcontrib>Tsubota, Kazuo</creatorcontrib><creatorcontrib>Ono, Masafumi</creatorcontrib><creatorcontrib>Nakai, Tomoko</creatorcontrib><creatorcontrib>Tan, Donald</creatorcontrib><creatorcontrib>Tanaka, Shiro</creatorcontrib><creatorcontrib>Kinoshita, Shigeru</creatorcontrib><creatorcontrib>ATOM-J. Study Group</creatorcontrib><creatorcontrib>the ATOM-J. Study Group</creatorcontrib><title>Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study</title><title>Japanese journal of ophthalmology</title><addtitle>Jpn J Ophthalmol</addtitle><addtitle>Jpn J Ophthalmol</addtitle><description>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  &lt; 0.001) for SE and − 0.14 mm (−0.20, −0.08; P  &lt; 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.</description><subject>Astigmatism</subject><subject>Atropine</subject><subject>Childhood</subject><subject>Children</subject><subject>Clinical Investigation</subject><subject>Confidence intervals</subject><subject>Conjunctivitis</subject><subject>Hay fever</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Myopia</subject><subject>Ophthalmology</subject><subject>Placebos</subject><subject>Safety</subject><subject>Side effects</subject><issn>0021-5155</issn><issn>1613-2246</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kUtrFjEUhoMo9rP6B1yUgBTcTD25zSTLUuoFCm50HTK5tFNmkmkyUzr--ubzaxVcuArkPOfJS16E3hM4IwDdp0KASd4AJQ2ApLTZXqAdaQlrKOXtS7SD_UgQIY7Qm1JuAYBTRl-jI8aEbEHBDj1chjBYYzdsosPFBL9sOAUMZ0BOsVlymofocUgZz9nf-7gMKe4BezOM7iYlh6etMgYPERtcM3iTca6yNA2_vMPzaKzvU2NTrLJxrFdlWd32Fr0KZiz-3dN5jH5-vvxx8bW5-v7l28X5VWO5okvDWMfA8QCWhtY4Lpjpa3ZCfEckV0pIa0VwtG05SOiDC63qvQugmOlkb9gx-njwzjndrb4sehqK9eNook9r0ZRL1QKVQlb0wz_obVpzrOk0FUTJjigBlaIHyuZUSvZBz3mYTN40Ab3vRR960fXz9e9e9FaXTp7Uaz9592fluYgKsANQ6ihe-_z37f9oHwE73JiI</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Hieda, Osamu</creator><creator>Hiraoka, Takahiro</creator><creator>Fujikado, Takashi</creator><creator>Ishiko, Satoshi</creator><creator>Hasebe, Satoshi</creator><creator>Torii, Hidemasa</creator><creator>Takahashi, Hiroshi</creator><creator>Nakamura, Yo</creator><creator>Sotozono, Chie</creator><creator>Oshika, Tetsuro</creator><creator>Morimoto, Takeshi</creator><creator>Nishida, Kohji</creator><creator>Nishikawa, Noriko</creator><creator>Song, Young-Seok</creator><creator>Tokutake, Tomoki</creator><creator>Nishi, Yasuyo</creator><creator>Shigeno, Yuta</creator><creator>Kurihara, Toshihide</creator><creator>Negishi, Kazuno</creator><creator>Tsubota, Kazuo</creator><creator>Ono, Masafumi</creator><creator>Nakai, Tomoko</creator><creator>Tan, Donald</creator><creator>Tanaka, Shiro</creator><creator>Kinoshita, Shigeru</creator><general>Springer Japan</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20210501</creationdate><title>Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c492t-33730d4f0c2f6ad453ab58611e71849958cc5fd2664080bfdf69bedf093a78ba3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Astigmatism</topic><topic>Atropine</topic><topic>Childhood</topic><topic>Children</topic><topic>Clinical Investigation</topic><topic>Confidence intervals</topic><topic>Conjunctivitis</topic><topic>Hay fever</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Myopia</topic><topic>Ophthalmology</topic><topic>Placebos</topic><topic>Safety</topic><topic>Side effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hieda, Osamu</creatorcontrib><creatorcontrib>Hiraoka, Takahiro</creatorcontrib><creatorcontrib>Fujikado, Takashi</creatorcontrib><creatorcontrib>Ishiko, Satoshi</creatorcontrib><creatorcontrib>Hasebe, Satoshi</creatorcontrib><creatorcontrib>Torii, Hidemasa</creatorcontrib><creatorcontrib>Takahashi, Hiroshi</creatorcontrib><creatorcontrib>Nakamura, Yo</creatorcontrib><creatorcontrib>Sotozono, Chie</creatorcontrib><creatorcontrib>Oshika, Tetsuro</creatorcontrib><creatorcontrib>Morimoto, Takeshi</creatorcontrib><creatorcontrib>Nishida, Kohji</creatorcontrib><creatorcontrib>Nishikawa, Noriko</creatorcontrib><creatorcontrib>Song, Young-Seok</creatorcontrib><creatorcontrib>Tokutake, Tomoki</creatorcontrib><creatorcontrib>Nishi, Yasuyo</creatorcontrib><creatorcontrib>Shigeno, Yuta</creatorcontrib><creatorcontrib>Kurihara, Toshihide</creatorcontrib><creatorcontrib>Negishi, Kazuno</creatorcontrib><creatorcontrib>Tsubota, Kazuo</creatorcontrib><creatorcontrib>Ono, Masafumi</creatorcontrib><creatorcontrib>Nakai, Tomoko</creatorcontrib><creatorcontrib>Tan, Donald</creatorcontrib><creatorcontrib>Tanaka, Shiro</creatorcontrib><creatorcontrib>Kinoshita, Shigeru</creatorcontrib><creatorcontrib>ATOM-J. 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Study Group</aucorp><aucorp>the ATOM-J. Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study</atitle><jtitle>Japanese journal of ophthalmology</jtitle><stitle>Jpn J Ophthalmol</stitle><addtitle>Jpn J Ophthalmol</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>65</volume><issue>3</issue><spage>315</spage><epage>325</epage><pages>315-325</pages><issn>0021-5155</issn><eissn>1613-2246</eissn><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  &lt; 0.001) for SE and − 0.14 mm (−0.20, −0.08; P  &lt; 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.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>33586090</pmid><doi>10.1007/s10384-021-00822-y</doi><tpages>11</tpages></addata></record>
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subjects Astigmatism
Atropine
Childhood
Children
Clinical Investigation
Confidence intervals
Conjunctivitis
Hay fever
Medicine
Medicine & Public Health
Myopia
Ophthalmology
Placebos
Safety
Side effects
title Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study
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