Low-concentration atropine is an emerging therapy for myopia progression, but its efficacy and optimal concentration remain uncertain. Our study aimed to evaluate the efficacy and safety of low-concentration atropine eye drops at 0.05%, 0.025%, and 0.01% compared with placebo over a 1-year period.Design: Randomized, placebo-controlled, double-masked trial.Participants: A total of 438 children aged 4 to 12 years with myopia of at least À1.0 diopter (D) and astigmatism of À2.5 D or less.Methods: Participants were randomly assigned in a 1:1:1:1 ratio to receive 0.05%, 0.025%, and 0.01% atropine eye drops, or placebo eye drop, respectively, once nightly to both eyes for 1 year. Cycloplegic refraction, axial length (AL), accommodation amplitude, pupil diameter, and best-corrected visual acuity were measured at baseline, 2 weeks, 4 months, 8 months, and 12 months. Visual Function Questionnaire was administered at the 1-year visit.Main Outcome Measures: Changes in spherical equivalent (SE) and AL were measured, and their differences among groups were compared using generalized estimating equation.Results: After 1 year, the mean SE change was À0.27AE0.61 D, À0.46AE0.45 D, À0.59AE0.61 D, and À0.81AE0.53 D in the 0.05%, 0.025%, and 0.01% atropine groups, and placebo groups, respectively (P < 0.001), with a respective mean increase in AL of 0.20AE0.25 mm, 0.29AE0.20 mm, 0.36AE0.29 mm, and 0.41AE0.22 mm (P < 0.001). The accommodation amplitude was reduced by 1.98AE2.82 D, 1.61AE2.61 D, 0.26AE3.04 D, and 0.32AE2.91 D, respectively (P < 0.001). The pupil sizes under photopic and mesopic conditions were increased respectively by 1.03AE1.02 mm and 0.58AE0.63 mm in the 0.05% atropine group, 0.76AE0.90 mm and 0.43AE0.61 mm in the 0.025% atropine group, 0.49AE0.80 mm and 0.23AE0.46 mm in the 0.01% atropine group, and 0.13AE1.07 mm and 0.02AE0.55 mm in the placebo group (P < 0.001). Visual acuity and vision-related quality of life were not affected in each group.Conclusions: The 0.05%, 0.025%, and 0.01% atropine eye drops reduced myopia progression along a concentration-dependent response. All concentrations were well tolerated without an adverse effect on vision-related quality of life. Of the 3 concentrations used, 0.05% atropine was most effective in controlling SE progression and AL elongation over a period of 1 year. Ophthalmology 2019;126:113-124 ª 2018 by the American Academy of Ophthalmology Supplemental material available at www.aaojournal.org. Myopia is the most common ocular disorder worldwide with increasing prevalence over the past decades, predominantly in East Asia. [1][2][3][4] Its prevalence in young adults has been reported to be 96.5% in Korean military conscripts 5 and 94.9% in university students in China. 6 It is predicted that approximately half of the world's population will be myopic by 2050, with as much as 10% being highly myopic. 7,8 Notably, high myopia is associated with excessive eyeball growth leading to sight-threatening complications, including presenile cataract, glaucoma, retinal detachment, choro...

Purpose: To evaluate the efficacy and safety of 0.05%, 0.025%, and 0.01% atropine eye drops over 2 years to determine which is the optimal concentration for longer-term myopia control.Design: Randomized, double-masked trial extended from the Low-Concentration Atropine for Myopia Progression (LAMP) Study.Participants: Three hundred eighty-three of 438 children (87%) aged 4 to 12 years with myopia of at least e1.0 diopter (D) originally randomized to receive atropine 0.05%, 0.025%, 0.01%, or placebo once daily in both eyes in the LAMP phase 1 study were continued in this extended trial (phase 2).Methods: Children in the placebo group (phase 1) were switched to receive 0.05% atropine from the beginning of the second-year follow-up, whereas those in the 0.05%, 0.025%, and 0.01% atropine groups continued with the same regimen. Cycloplegic refraction, axial length (AL), accommodation amplitude, photopic and mesopic pupil diameter, and best-corrected visual acuity were measured at 4-month intervals.Main Outcome Measures: Changes in spherical equivalent (SE) and AL and their differences between groups.Results: Over the 2-year period, the mean SE progression was 0.55AE0.86 D, 0.85AE0.73 D, and 1.12AE0.85 D in the 0.05%, 0.025%, and 0.01% atropine groups, respectively (P ¼ 0.015, P < 0.001, and P ¼ 0.02, respectively, for pairwise comparisons), with mean AL changes over 2 years of 0.39AE0.35 mm, 0.50AE0.33 mm, and 0.59AE0.38 mm (P ¼ 0.04, P < 0.001, and P ¼ 0.10, respectively). Compared with the first year, the second-year efficacy of 0.05% and 0.025% atropine remained similar (P >0.1), but improved mildly in the 0.01% atropine group (P ¼ 0.04). For the phase 1 placebo group, the myopia progression was reduced significantly after switching to 0.05% atropine (SE change, 0.18 D in second year vs. 0.82 D in first year [P < 0.001]; AL elongated 0.15 mm in second year vs. 0.43 mm in first year [P < 0.001]). Accommodation loss and change in pupil size in all concentrations remained similar to the first-year results and were well tolerated. Visual acuity and vision-related quality of life remained unaffected.Conclusions: Over 2 years, the efficacy of 0.05% atropine observed was double that observed with 0.01% atropine, and it remained the optimal concentration among the studied atropine concentrations in slowing myopia progression. Ophthalmology 2020;127:910-919 ª 2019 by the American Academy of Ophthalmology Supplemental material available at www.aaojournal.org.Myopia is a public health threat worldwide, with increasing prevalence in most regions over the past decades and especially in East Asia. 1e4 Low-concentration atropine eye drops are an emerging therapy for myopia control, 5,6 but their optimal concentration and long-term efficacy remain undefined. In the first-year (phase 1) results of the Low-Concentration Atropine for Myopia Progression (LAMP) study, 0.05% atropine conferred the best treatment-to-side effect ratio among 0.05%, 0.025%, and 0.01% atropine over 1 year. 7 Of note, in the Atropine for the Treatment of Myopi...

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ImportanceEarly onset of myopia is associated with high myopia later in life, and myopia is irreversible once developed.ObjectiveTo evaluate the efficacy of low-concentration atropine eyedrops at 0.05% and 0.01% concentration for delaying the onset of myopia.Design, Setting, and ParticipantsThis 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.InterventionsParticipants 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.Main Outcomes and MeasuresThe 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).ResultsOf 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.Conclusions and RelevanceAmong 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.Trial RegistrationChinese Clinical Trial Registry: ChiCTR-IPR-15006883