Status:
UNKNOWN
Safety and Efficacy Study of 0.5%, 0.1% & 0.01% Atropine Treatment to Both Eyes In Treatment of Myopia In Children
Lead Sponsor:
Singapore National Eye Centre
Conditions:
Myopia
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to find an optimal dose of atropine for preventing the rapid progression of myopia in children by comparing the efficacy, safety and functional impact of binocular treatme...
Detailed Description
A Randomised, Double-Masked Study to Compare The Safety and Efficacy of Bilateral 0.5%, 0.1% \& 0.01% Atropine Treatment In Controlling Progression of Myopia In Children Study Duration and Visit Sche...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00371124
Start Date
March 1 2006
Last Update
August 31 2010
Active Locations (1)
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1
Singapore Eye Research Institute
Singapore, Singapore