ATOM Study 2006.
Study characteristics | |
Methods | Study design: parallel‐group RCT, with 2‐week run‐in period Study centre: 1 Number randomised: 400 children Study follow‐up: 2 years Exclusions and losses to follow‐up: no exclusions; 54 (13.5%) were lost to follow‐up |
Participants | Age: mean = 9.2 years (range 6‐12 years) Gender: 220 boys, 180 girls Culture: Chinese (94%) and Indian children (4%) in Singapore Inclusion criteria:
Exclusion criteria:
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Interventions | Atropine (n = 200): 1 eye was randomised to 1 drop of 1% atropine sulfate nightly; the other eye received nothing Placebo control (n = 200): 1 eye was randomised to 1 drop of vehicle nightly; the other eye received nothing Note: all children received single vision photochromatic lenses for correction of refractive errors |
Outcomes |
Primary efficacy outcome
Secondary efficacy outcome
Primary safety outcome
Secondary safety outcomes
Measurements taken at baseline and annually for 2 years Note: baseline measurements recorded 2 weeks after treatment began to allow for stabilisation of the cycloplegic effect of atropine Unit of analysis: only 1 eye per child randomised to receive treatment (fellow eyes were controls) |
Notes | Study dates: enrolment between April 1999 and September 2000 Trial registration: not reported Materials: vehicle drops were prepared by Alcon Laboratories; spectacles were SOLA Transitions SVLs Funding source: National Medical Research Council, Singapore Additional data: study author provided unpublished data via email correspondence |