Trial of Myopia Prevention Using +3D Lenses

Not Applicable

• Conditions: Myopia

• Registration Number: NCT00627874
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

Detailed Description

1. To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children.

2. To identify ocular parameters and risk factors at baseline associated with development and progression of myopia.

Study Timeline

• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-24
• Study First Posted: 2008-03-04
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-20
• Last Update Posted: 2009-02-24
• Study Start: 2010-04
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• All children in the selected class are enrolled

Exclusion Criteria

• Hyperopia > +2.0 D
• High myopia > -6.0 D
• Astigmatism> 1.5 D
• Anisometropia > 1.5 D
• Strabismus and amblyopia
• Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development
• Chronic medication use that might affect myopia progression or visual acuity
• Already receiving other treatment for progressing myopia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial Length of eyes	Annual

Secondary Outcome Measures

Name	Time	Method
Autorefraction	Annual