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Atropine in the Treatment of Myopia Study in Malaysia (ATOM-MY): A Randomized, Double-Blind Study to Demonstrate the Efficacy and Safety of Eye Drop Formulations (Atropine Sulphate 0.025 % w/v Eye Drops vs Placebo) in the Management of Controlling Progression of Myopia in Children.
This clinical trial is designed to assess the efficacy and safety of Atropine Sulphate 0.025% w/v Eye Drops compared to placebo in a randomized, double-blind, placebo-controlled study for the management of myopia progression in children.
Myopia represents the most prevalent refractive error globally, with its incidence rising significantly over recent decades, particularly in East Asian populations. Current projections estimate that by the year 2050, nearly 50% of the global population will be affected by myopia, with approximately 10% classified as high myopes. High myopia is characterized by axial elongation of the eye and is associated with an elevated risk of severe ocular complications, including early-onset cataracts, glaucoma, retinal detachment, choroidal neovascularization, myopic macular degeneration, and macular hemorrhage. Given its increasing prevalence and potential for vision-threatening outcomes, myopia constitutes a substantial public health issue, contributing to considerable healthcare and socioeconomic burdens. Therefore, the development of safe and effective interventions to mitigate the progression of myopia is of critical importance.
Age
5 - 10 years
Sex
ALL
Healthy Volunteers
No
Hospital Pakar Kanak-Kanak UKM
Kuala Lumpur, Cheras, Malaysia
Universiti Malaya Medical Centre
Kuala Lumpur, Petaling Jaya, Malaysia
Start Date
September 17, 2025
Primary Completion Date
September 1, 2027
Completion Date
September 1, 2029
Last Updated
January 9, 2026
144
ESTIMATED participants
Low dose atropine sulfate eye drops
DRUG
Placebo
DRUG
Lead Sponsor
IDB VisionCare SDN BHD
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT03952702