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OpenTrials
Active, Not Recruiting

NCT Number: NCT03140358

The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)

Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Singapore eye research institute

Singapore, 423699

About this study

High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • One parent with myopia (<-3D in at least one eye)
  • SE +1.00D to -1.50D
  • Astigmatism < = 1.50D
  • Distance vision logMAR 0.2 or better in both eyes
  • Intraocular pressure of not greater than 21 mmHg
  • No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion criteria

  • Any eye or systemic disease that affect vision or refractive error
  • Conditions where topical atropine contraindicated
  • Previous use of atropine or pirenzepine
  • Known past/current amblyopia or strabismus

Treatment and study plan

Atropine sulfate 0.01%

Drug

Atropine 0.01%

Placebo

Drug

placebo

Primary outcomes

  1. Spherical Equivalent

    Time frame: 3.5 years

    SE

Secondary outcomes

  1. Axial Length

    Time frame: 3.5 years

    AL

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
May 4, 2017
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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