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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03140358

Enrollment

300

Registered

2017-05-04

Start date

2017-04-21

Completion date

2025-12-31

Last updated

2025-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DRUGAtropine sulfate 0.01%

Atropine 0.01%

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized control trial

Eligibility

Sex/Gender

ALL

Age

5 Years to 9 Years

Healthy volunteers

Yes

Inclusion criteria

1. One parent with myopia (\<-3D in at least one eye) 2. SE +1.00D to -1.50D 3. Astigmatism \< = 1.50D 4. Distance vision logMAR 0.2 or better in both eyes 5. Intraocular pressure of not greater than 21 mmHg 6. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

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

Design outcomes

Primary

Measure	Time frame	Description
Spherical Equivalent	3.5 years	SE

Secondary

Measure	Time frame	Description
Axial Length	3.5 years	AL

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026