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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Drug: Placebo; Drug: Atropine sulfate 0.01%

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 423699
    • Singapore Eye Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Premyopia atropine; On Atropine 0.01%	Drug: Atropine sulfate 0.01%; Atropine 0.01%
Placebo Comparator: Premyopia placebo; On placebo	Drug: Placebo; placebo
Active Comparator: Low myopia atropine; On Atropine 0.01% daily or every other day	Drug: Atropine sulfate 0.01%; Atropine 0.01%
Placebo Comparator: Low myopia placebo; On placebo	Drug: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical Equivalent	SE	3.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial Length	AL	3.5 years

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Collaborators: National Medical Research Council (NMRC), Singapore
• Investigators: Principal Investigator: Audrey Chia, Singapore National Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adjuvants, Anesthesia; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Mydriatics; Atropine
• Other Study ID Numbers: R1359/45/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No