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.
• Male or female children between 5 to 10 years of age.
• Children with refractive error of spherical equivalent -1.00 D up to -6.00 D in each eye.
• Children with active myopia progression of at least spherical equivalent -0.50 D within the last 12 months.
• Children with astigmatism of less than -1.50 D
• Children having distance vision correctable to logMAR 0.2 or better in both eyes.
• A difference between non-cycloplegic subjective spherical refraction and cycloplegic subjective spherical refraction of not greater than -1.00 D.
• Children with normal intraocular pressure of not greater than 21 mmHg in either eye.
• Children with normal ocular health other than myopia.
• Children must be in good general health with no history of cardiac or respiratory diseases as per investigator's discretion and does not affect the study treatment or subsequent follow-ups.
⁃ No asthma-requiring medications in the past one year.
⁃ No known allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride.
⁃ Willing and able to comply with scheduled visits and other study procedures.
⁃ Written Informed Consent from parent and assent from child has been obtained.