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W Chua, V Balakrishnan, Y ChanATOM Study Group; Analysis of Safety Data for Atropine in the Treatment Of Myopia (ATOM) Study . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3329.
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Purpose: Previous studies on the use of atropine for controlling myopia progression paid little attention to the safety aspects of long-term treatment. We now report on the analysis of the safety data from the ATOM study. Methods: The ATOM study is a randomized, double-masked placebo-controlled trial designed to assess the safety and efficacy of topical atropine in controlling childhood myopia. 400 hundred eligible children aged 6-12 years, with myopia between -1 to -6 D in each eye were, after informed consent, enrolled and randomized to receive either 1% atropine eye drop or Isoptotears once nightly in one eye only. All subjects were prescribed photochromatic lenses. The following safety parameters were evaluated at the screening visit and at 4-monthly intervals: 1) best corrected logMAR visual acuity (BCVA), 2) IOP by air-puff tonometry, 3) anterior segment, disc and macular changes by slitlamp biomicroscopy and ophthalmoscopy, and 4) symptom questionnaire and self-reporting. As per study protocol, an anaylsis of the 1-year data from the first 200 subjects was undertaken without breaking the randomization codes. Results: For the 178 (89%) subjects who remained in the study at 1 year, there was no clinically significant deterioration in BCVA but rather an improvement of the logMAR score by 0.04 +/- 0.06. Similarly, IOP changes were within 5.5 mmHg with no absolute readings above 21 mmHg. No lenticular, disc or macular changes were reported. Reasons for withdrawal were: allergic/hypersensitivity reactions or discomfort (4.5%); glare (1.5%); blurred near vision (1%); logistical difficulties (3.5%); others (0.5%). Conclusion: The ATOM study does not identify specific immediate safety concerns of prolonged atropine use, a treatment that is generally well tolerated. Specifically, unilateral atropine treatment in children aged 6 and above does not result in amblyopia. Other safety variables such as accommodative amplitude will be assessed upon completion of the study.
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