Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control

作者：Michael X. Repka, Katherine K. Weise, Danielle L. Chandler, Rui Wu, Michele Melia, Ruth E. Manny, Lori Ann F. Kehler, Catherine O. Jordan, Aparna Raghuram, Allison I. Summers, Katherine A. Lee, David B. Petersen, S. Ayse Erzurum, Yi Pang, Phoebe D. Lenhart, Benjamin H. Ticho, Roy W. Beck, Raymond T. Kraker, Jonathan M. Holmes, Susan A. Cotter, Pediatric Eye Disease Investigator Group, Denise D. Alexopoulous, Megan Allen, Heather A. Anderson, Darrell S. Austin, S. Black, Nicole M. Boyle, Grant Andrew Casey, Moriah A. Chandler, Ryan N. Chinn, Deborah A. Clausius, Cynthia Benedict J, Courtney L. Conner, Linda Curtis, Zainab Dinani, Quayleen Donahue, Michelle Dubois, Patricia Evans, Brooke P. Fimbel, Melanie Kay Fowler, Richard P. Golden, B Harper, Robert J. Henderson, Dieu-Hong Ho, James E. Hoepner, Kristine B. Hopkins, Ashli S. Jenks, Joseph D. Kaplon, Shabana Khan, Cassandra A. Koutnik, Annie Kuo, Jessy Lee, Muriel M. Martinez, Sophia Marusic, Mary Lou McGregor, J. Ryan McMurtrey, Kathryn B. Miller, Preeti L. Mokka, Jenifer Montejo, Beth A. Morrell, Elyse Nylin, Kimberly C. Odom, Gillaine Ortiz, Samantha A. Parra, Kyle J. Perkins, Larry W. Plum, Ellen Redenbo, Julianne L. Robinson, Kathleen M. Stutz, Desirae R. Sutherland, Mircea X. Teodorescu, Lori L. Torgensen, David O. Toro, Phillip B. Turner, Natalie C. Weil, Emily Wiecek, C. Wilkins, Victoria C. Woodard, K. Woodruff, Huizi Yin, Marika L. Yumang, Tomohiko Yamada, Noha S. Ekdawi, David A. Leske, David K. Wallace, Melanie Christian, Stephen R. Glaser, Eileen E. Birch, Angela M. Chen, Stephen P. Christiansen, Laura B. Enyedi, Donald F. Everett, Sharon F. Freedman, William V. Good, Erin C. Jenewein, Richard London, Vivian M. Manh, David G. Morrison, Stacy L. Pineles, Hantamalala Ralay Ranaivo, Tawna L. Roberts, Scott T. Ruark, Bonita R. Schweinler, Jayne L. Silver, Donny W. Suh, Lisa C. Verderber, Marie Diener‐West, John D. Baker, Barry R. Davis, Rosemary D. Higgins, Stephen W. Poff, Richard Saunders, Lawrence Tychsen · 发表于：JAMA Ophthalmology · 年份：2023 · DOI：10.1001/jamaophthalmol.2023.2855 · 被引用次数：124 · 研究领域：Ophthalmology and Visual Impairment Studies、Retinopathy of Prematurity Studies、Glaucoma and retinal disorders

Importance: Controlling myopia progression is of interest worldwide. Low-dose atropine eye drops have slowed progression in children in East Asia. Objective: To compare atropine, 0.01%, eye drops with placebo for slowing myopia progression in US children. Design, Setting, and Participants: This was a randomized placebo-controlled, double-masked, clinical trial conducted from June 2018 to September 2022. Children aged 5 to 12 years were recruited from 12 community- and institution-based practices in the US. Participating children had low to moderate bilateral myopia (-1.00 diopters [D] to -6.00 D spherical equivalent refractive error [SER]). Intervention: Eligible children were randomly assigned 2:1 to 1 eye drop of atropine, 0.01%, nightly or 1 drop of placebo. Treatment was for 24 months followed by 6 months of observation. Main Outcome and Measures: Automated cycloplegic refraction was performed by masked examiners. The primary outcome was change in SER (mean of both eyes) from baseline to 24 months (receiving treatment); other outcomes included change in SER from baseline to 30 months (not receiving treatment) and change in axial length at both time points. Differences were calculated as atropine minus placebo. Results: A total of 187 children (mean [SD] age, 10.1 [1.8] years; age range, 5.1-12.9 years; 101 female [54%]; 34 Black [18%], 20 East Asian [11%], 30 Hispanic or Latino [16%], 11 multiracial [6%], 6 West/South Asian [3%], 86 White [46%]) were included in the study...