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NCT03140358 Clinical Trial

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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03140358
Other study ID # R1359/45/2016
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 21, 2017
Est. completion date December 31, 2025

Study information
Verified date March 2023
Source Singapore National Eye Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 9 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Atropine sulfate 0.01%
Atropine 0.01%
• Placebo
placebo

Locations
Country Name City State
Singapore Singapore eye research institute Singapore

Sponsors (2)
Lead Sponsor Collaborator
Singapore National Eye Centre National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spherical Equivalent SE 3.5 years
Secondary Axial Length AL 3.5 years
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