The Efficacy of 0.01% Atropine Ophthalmic Solution for Controlling the Progression of Childhood Myopia (ATOM-J Study)
- Conditions
- Mild or moderate myopia
- Registration Number
- JPRN-UMIN000018041
- Lead Sponsor
- Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 180
Not provided
(1) Children with abnormal visual function bilaterally (2) Children with amblyopia or manifest strabismus (3) Children with difference in objective spherical equivalent with and without cycloplegia of more than 1.00D in each eye (4) Children with ocular disorders other than myopia (5) Children with ocular or systemic disorders that potentially affect myopia or refractive power (6) Children who have received previous treatment for myopia that included atropine therapy such as contact lenses, bifocal lenses, or progressive lenses with atropine therapy (however, this does not apply to children who discontinued 0.4% tropicamide ophthalmic solution at least 3 months previously) (7) Children with a history of cardiovascular or respiratory disease (8) Children who have received pharmacotherapy for asthma in the past year (9) Children with a history of allergy to atropine, cyclopentolate, or benzalkonium (10) Children who cannot instill medication into the eye (11) Children who may require contact lenses, bifocal lenses, or progressive lenses during the clinical study period (12) Children deemed otherwise unsuitable for the study by the (sub)investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in objective spherical equivalent at the end of 24 months of drug treatment.
- Secondary Outcome Measures
Name Time Method