Original articleFive-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops
Section snippets
Methods
In phase 1 of the ATOM2 study (treatment phase), 400 Asian children (aged 6–12 years) with myopia of −2.00 D or worse in each eye were randomized to receive atropine 0.01%, 0.1%, and 0.5% once nightly in both eyes for 2 years. Children were assigned to treatment in a 1:2:2 ratio, stratified by 6 gender and age strata. In phase 2 (washout phase), atropine was stopped and children were monitored for 12 months. In phase 3 (re-treatment phase), children who exhibited myopia progression of −0.50 D
Results
Among the 400 children enrolled in the study, 44 were lost in phase 1 and 11 were lost in phase 2, with 345 (86%) continuing to phase 3 (Fig 1). Children still in the study at the start of phase 3 were more myopic at baseline but had less myopic progression over the first year compared with children who were lost to follow-up (Table 1). The majority of the children (91%) were of ethnic Chinese origin.
Of the 345 children, 192 (56%) were restarted on atropine 0.01% because they had progressed 0.5
Discussion
In our first randomized placebo-controlled clinical trial using atropine eyedrops to control myopia progression in children (ATOM1), we established the clinical safety and efficacy of atropine 1% at least in the short term.16, 18 In phase 1 of ATOM2, we established that atropine 0.01% was almost as effective in reducing myopia progression as higher concentrations but with minimal pupil dilation accommodation and near vision loss.19, 20 In phase 2, we further established that children receiving
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See Editorial on page 232.
Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Supported by grants from the National Medical Research Council (MH 95:03/1-23) and SingHealth (SHF/FG039/2004 and TEST 08-03).
Author Contributions:
Conception and design: Chia, Lu, Tan
Data acquisition and/or research execution: Chia, Lu, Tan
Analysis and interpretation: Chia, Lu, Tan
Obtained funding: Tan
Overall responsibility: Chia, Lu, Tan