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Yam, Jason C.; Zhang, Xiu Juan; Zhang, Yuzhou; Yip, Benjamin H. K.; Tang, Fangyao; Wong, Emily S.; Bui, Christine H. T.; Kam, Ka Wai; Ng, Mandy P. H.; Ko, Simon T.; Yip, Wilson W.K.; Young, Alvin L.; Tham, Clement C.; Chen, Li Jia; Pang, Chi Pui

Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children : The LAMP2 Randomized Clinical Trial

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  • Medientyp: E-Artikel
  • Titel: Effect of Low-Concentration Atropine Eyedrops vs Placebo on Myopia Incidence in Children : The LAMP2 Randomized Clinical Trial : The LAMP2 Randomized Clinical Trial
  • Beteiligte: Yam, Jason C.; Zhang, Xiu Juan; Zhang, Yuzhou; Yip, Benjamin H. K.; Tang, Fangyao; Wong, Emily S.; Bui, Christine H. T.; Kam, Ka Wai; Ng, Mandy P. H.; Ko, Simon T.; Yip, Wilson W.K.; Young, Alvin L.; Tham, Clement C.; Chen, Li Jia; Pang, Chi Pui
  • Erschienen: American Medical Association (AMA), 2023
  • Erschienen in: JAMA
  • Sprache: Englisch
  • DOI: 10.1001/jama.2022.24162
  • ISSN: 0098-7484
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Importance</jats:title><jats:p>Early onset of myopia is associated with high myopia later in life, and myopia is irreversible once developed.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the efficacy of low-concentration atropine eyedrops at 0.05% and 0.01% concentration for delaying the onset of myopia.</jats:p></jats:sec><jats:sec><jats:title>Design, Setting, and Participants</jats:title><jats:p>This randomized, placebo-controlled, double-masked trial conducted at the Chinese University of Hong Kong Eye Centre enrolled 474 nonmyopic children aged 4 through 9 years with cycloplegic spherical equivalent between +1.00 D to 0.00 D and astigmatism less than −1.00 D. The first recruited participant started treatment on July 11, 2017, and the last participant was enrolled on June 4, 2020; the date of the final follow-up session was June 4, 2022.</jats:p></jats:sec><jats:sec><jats:title>Interventions</jats:title><jats:p>Participants were assigned at random to the 0.05% atropine (n = 160), 0.01% atropine (n = 159), and placebo (n = 155) groups and had eyedrops applied once nightly in both eyes over 2 years.</jats:p></jats:sec><jats:sec><jats:title>Main Outcomes and Measures</jats:title><jats:p>The primary outcomes were the 2-year cumulative incidence rate of myopia (cycloplegic spherical equivalent of at least −0.50 D in either eye) and the percentage of participants with fast myopic shift (spherical equivalent myopic shift of at least 1.00 D).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 474 randomized patients (mean age, 6.8 years; 50% female), 353 (74.5%) completed the trial. The 2-year cumulative incidence of myopia in the 0.05% atropine, 0.01% atropine, and placebo groups were 28.4% (33/116), 45.9% (56/122), and 53.0% (61/115), respectively, and the percentages of participants with fast myopic shift at 2 years were 25.0%, 45.1%, and 53.9%. Compared with the placebo group, the 0.05% atropine group had significantly lower 2-year cumulative myopia incidence (difference, 24.6% [95% CI, 12.0%-36.4%]) and percentage of patients with fast myopic shift (difference, 28.9% [95% CI, 16.5%-40.5%]). Compared with the 0.01% atropine group, the 0.05% atropine group had significantly lower 2-year cumulative myopia incidence (difference, 17.5% [95% CI, 5.2%-29.2%]) and percentage of patients with fast myopic shift (difference, 20.1% [95% CI, 8.0%-31.6%]). The 0.01% atropine and placebo groups were not significantly different in 2-year cumulative myopia incidence or percentage of patients with fast myopic shift. Photophobia was the most common adverse event and was reported by 12.9% of participants in the 0.05% atropine group, 18.9% in the 0.01% atropine group, and 12.2% in the placebo group in the second year.</jats:p></jats:sec><jats:sec><jats:title>Conclusions and Relevance</jats:title><jats:p>Among children aged 4 to 9 years without myopia, nightly use of 0.05% atropine eyedrops compared with placebo resulted in a significantly lower incidence of myopia and lower percentage of participants with fast myopic shift at 2 years. There was no significant difference between 0.01% atropine and placebo. Further research is needed to replicate the findings, to understand whether this represents a delay or prevention of myopia, and to assess longer-term safety.</jats:p></jats:sec><jats:sec><jats:title>Trial Registration</jats:title><jats:p>Chinese Clinical Trial Registry: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.chictr.org.cn/showproj.aspx?proj=11597">ChiCTR-IPR-15006883</jats:ext-link></jats:p></jats:sec>