Trial of Myopia Prevention Using +3D Lenses (PLS)

Sun Yat-sen University

Status: Unknown

Conditions: Myopia

Treatments: Device: +3D Lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT00627874

PLS2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Device: +3D Lenses

2

No Intervention group