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The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression

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研究单位: [1]Beijing Tongren Hospital Affiliated to Capital Medical University [2]Seefunge Pharmaceutical Technology Co., Ltd. [3]Hefei Maternal and Child Health Hospital,Hefei,Anhui,China [4]The Second Hospital of Anhui Medical University,Hefei,Anhui,China [5]Xuancheng People''s Hospital,Xuancheng,Anhui,China [6]The Second Hospital of Lanzhou University,Lanzhou,Gansu,China [7]Liuzhou People''s Hospital,Liuzhou,Guangxi Zhuang Autonomous Region,China [8]The People''s Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi Zhuang Autonomous Region,China [9]The Affiliated Hospital of Guizhou Medical University,Guiyang,Guizhou,China [10]The First People''s Hospital of Zunyi,Zunyi,Guizhou,China [11]Daqingshi People''s Hospital,Daqing,Heilongjiang,China [12]Kaifeng Central Hospital,Kaifeng,Henan,China [13]The First Affiliated Hospital of University of South China,Hengyang,Hunan,China [14]Huai''an First People''s Hospital,Huai''an,Jiangsu,China [15]Affiliated Eye Hospital of Nanchang University,Nanchang,Jiangxi,China [16]The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China [17]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China [18]Weifang Eye Hospital,Weifang,Shandong,China [19]Heping Hospital Affiliated to Changzhi Medical College,Changzhi,Shanxi,China [20]Shanxi Eye Hospital,Taiyuan,Shanxi,China [21]Xianyang Hospital of Yan''an University,Xianyang,Shanxi,China [22]Zhejiang Provincial People''s Hospital,Hangzhou,Zhejiang,China [23]Beijing Tongren Hospital Affiliated to Capital Medical University,Beijing,China [24]Peking University Third Hospital,Beijing,China [25]Chongqing Aier Eye Hospital,Chongqing,China [26]Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital),Shanghai,China [27]Tianjin Medical University Eye Hospital,Tianjin,China

关键词: Myopia Atropine

研究目的:
The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents. Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) in delaying myopia progression in children and adolescents. Exploratory Objective: 1. the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks. 2. evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.

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