Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children
Myopia
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia treatment, Atropine
Eligibility Criteria
Inclusion Criteria: Written Informed Consent from parent and assent from child has been obtained Children aged 6 to 12 years Refractive error of spherical equivalent -2.00 D or worse in each eye as measured by cycloplegic autorefraction Active myopia progression of at least spherical equivalent -0.50 D over the last 12 months as determined or suggested by refractive records or change in lens power Astigmatism of less than or equal to -1.50 D as measured by cycloplegic or non-cycloplegic autorefraction 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 Normal intraocular pressure of not greater than 21 mmHg Normal ocular health other than myopia In good general health with no history of cardiac or significant respiratory diseases No asthma-requiring medications in the past one year No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride Willing and able to comply with scheduled visits and other study procedures Exclusion Criteria: Ocular or systemic diseases which may affect vision or refractive error Any ocular condition wherein topical atropine is contraindicated Defective binocular function or stereopsis Amblyopia or manifest strabismus including intermittent tropia Previous or current use of atropine or pirenzepine Any other conditions precluding adherence to the protocol including unwillingness to refrain from contact lens wear for the duration of the study
Sites / Locations
- Singapore Eye Research Institute