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

Phase 3

Active, not recruiting

• Conditions: Myopia
• Interventions: Drug: Placebo; Drug: Atropine sulfate 0.01%

• Registration Number: NCT03140358
• Lead Sponsor: Singapore National Eye Centre

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-04-21
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Primary Completion: 2024-12-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Premyopia placebo	Placebo	On placebo
Low myopia atropine	Atropine sulfate 0.01%	On Atropine 0.01% daily or every other day
Low myopia placebo	Placebo	On placebo
Premyopia atropine	Atropine sulfate 0.01%	On Atropine 0.01%

Primary Outcome Measures

Name	Time	Method
Spherical Equivalent	3.5 years	SE

Secondary Outcome Measures

Name	Time	Method
Axial Length	3.5 years	AL

Trial Locations

Locations (1)

Singapore eye research institute; 🇸🇬 Singapore, Singapore