Trial of Myopia Prevention Using +3D Lenses

Myopia Clinical Trial

— PLS  

Official title:

A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00627874
• Other study ID #: PLS2008
• Status: Not yet recruiting
• Phase: N/A
• First received: February 20, 2008
• Last updated: February 20, 2009
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2009
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• +3D Lenses
wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Australian National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Length of eyes		Annual	No
Secondary	Autorefraction		Annual	No