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W. Chua, V. Balakrishnan, D. Tan, Y. Chan, ATOM Study Group; Efficacy Results from the Atropine in the Treatment of Myopia (ATOM) Study . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3119.
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Purpose: The Atropine in the Treatment Of Myopia (ATOM) study is a randomized, double-masked, placebo-controlled trial designed to assess the safety and efficacy of topical atropine in controlling the progression of myopia in children. We had previously described the safety issues related to the treatment (ARVO abstract #3329, 2002). We now report the efficacy results from the study. Methods: Four hundred eligible children aged 6-12 years, with myopia of -1 D to -6 D, were enrolled after informed consent and randomly assigned with equal probability to receive either 1% atropine eye drop or Isoptotears once nightly. Only one eye of each child was chosen (also via randomization) for treatment. Subjects were followed-up at 4-monthly intervals for 2 years. At each visit, cycloplegic autorefraction (primary outcome measure) and ultrasound A-scan biometry (secondary outcome measure) were performed. Analyses were performed following the intention-to-treat principle. Results: 359 (90%) subjects returned for the 1-year follow-up visit and 331 (83%) subjects completed the 2-year study. Of the 69 subjects who did not complete the study, 21 were from the control group and 48 from the atropine group. At 1 year, the mean myopia progression in the placebo-control eyes was -0.76 D ± 0.44 D. In the atropine-treated eyes however, there was a regression of myopia by +0.3 D ± 0.50 D (p < 0.0001). Concomitantly, the mean axial elongation in the placebo-control eyes was +0.20 mm ± 0.30 mm but in the atropine-treated eyes there was a reduction in axial length by -0.14 mm ± 0.28 mm (p < 0.0001). After 2 years, the mean myopia progression and axial elongation in the placebo-control eyes were -1.20 D ± 0.69 D and +0.38 mm ± 0.38 mm respectively. In the atropine-treated eyes, myopia progression was only -0.25 D ± 0.92 D while the axial length remained essentially unchanged compared to baseline (-0.02 mm ± 0.35 mm). The differences in both myopia progression and axial elongation between the two groups where both statistically (p < 0.0001) and clinically significant. Conclusions: The ATOM study is the largest randomized controlled trial of its kind to date and the results provide strong evidence that childhood myopia progression and axial elongation can be controlled through pharmacological means such as topical atropine.
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