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. 2023 Feb 16;2023(2):CD014758. doi: 10.1002/14651858.CD014758.pub2

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: 
  • age 6‐12 years

  • myopia with SER error between −1.00 D and −6.00 D in each eye as measured by cycloplegic autorefraction

  • distance vision correctable to logMAR 0.2 or better in both eyes

  • normal ocular health

  • good general health with no history of cardiac or significant respiratory disease

  • normal binocular function and stereopsis

  • willingness and ability to tolerate monocular cycloplegia and mydriasis


Exclusion criteria: 
  • astigmatism > −1.50 D by cycloplegic autorefraction

  • IOP ≥ 21 mmHg

  • allergies to atropine, cyclopentolate, proparacaine, or benzalkonium chloride 

  • previous or current use of contact lenses, BFs, PALs, or other forms of myopia treatment

  • amblyopia or manifest strabismus, including intermittent tropia

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
  • Progression of myopia defined as the change in SER error from baseline and measured by cycloplegic autorefraction


Secondary efficacy outcome
  • Change in AL from baseline and measured by A‐scan ultrasonography


Primary safety outcome
  • Occurrence of AEs


Secondary safety outcomes
  • BCVA, IOP, slit‐lamp biomicroscopy, fundus examination


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