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 |
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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 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2489602858</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2519871950</sourcerecordid><originalsourceid>FETCH-LOGICAL-c492t-33730d4f0c2f6ad453ab58611e71849958cc5fd2664080bfdf69bedf093a78ba3</originalsourceid><addsrcrecordid>eNp9kUtrFjEUhoMo9rP6B1yUgBTcTD25zSTLUuoFCm50HTK5tFNmkmkyUzr--ubzaxVcuArkPOfJS16E3hM4IwDdp0KASd4AJQ2ApLTZXqAdaQlrKOXtS7SD_UgQIY7Qm1JuAYBTRl-jI8aEbEHBDj1chjBYYzdsosPFBL9sOAUMZ0BOsVlymofocUgZz9nf-7gMKe4BezOM7iYlh6etMgYPERtcM3iTca6yNA2_vMPzaKzvU2NTrLJxrFdlWd32Fr0KZiz-3dN5jH5-vvxx8bW5-v7l28X5VWO5okvDWMfA8QCWhtY4Lpjpa3ZCfEckV0pIa0VwtG05SOiDC63qvQugmOlkb9gx-njwzjndrb4sehqK9eNook9r0ZRL1QKVQlb0wz_obVpzrOk0FUTJjigBlaIHyuZUSvZBz3mYTN40Ab3vRR960fXz9e9e9FaXTp7Uaz9592fluYgKsANQ6ihe-_z37f9oHwE73JiI</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2519871950</pqid></control><display><type>article</type><title>Efficacy and safety of 0.01% atropine for prevention of childhood myopia in a 2-year randomized placebo-controlled study</title><source>SpringerLink Journals</source><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</creator><creatorcontrib>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 ; ATOM-J. 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
< 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.</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 & 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
< 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.</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 & 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 & 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. Study Group</creatorcontrib><creatorcontrib>the ATOM-J. Study Group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Japanese journal of ophthalmology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hieda, Osamu</au><au>Hiraoka, Takahiro</au><au>Fujikado, Takashi</au><au>Ishiko, Satoshi</au><au>Hasebe, Satoshi</au><au>Torii, Hidemasa</au><au>Takahashi, Hiroshi</au><au>Nakamura, Yo</au><au>Sotozono, Chie</au><au>Oshika, Tetsuro</au><au>Morimoto, Takeshi</au><au>Nishida, Kohji</au><au>Nishikawa, Noriko</au><au>Song, Young-Seok</au><au>Tokutake, Tomoki</au><au>Nishi, Yasuyo</au><au>Shigeno, Yuta</au><au>Kurihara, Toshihide</au><au>Negishi, Kazuno</au><au>Tsubota, Kazuo</au><au>Ono, Masafumi</au><au>Nakai, Tomoko</au><au>Tan, Donald</au><au>Tanaka, Shiro</au><au>Kinoshita, Shigeru</au><aucorp>ATOM-J. 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
< 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.</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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source | SpringerLink Journals |
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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