PLS: Trial of Myopia Prevention Using +3D Lenses

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00627874
• Collaborator: Australian National University (Other)
• Enrollment: 1,200
• Arms: 2
• Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: +3D Lenses	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children
• Study Start Date: Apr 1, 2010
• Anticipated Primary Completion Date: Apr 1, 2012
• Anticipated Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m	Device: +3D Lenses; wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
No Intervention: 2

Outcome Measures

Primary Outcome Measures

1. Axial Length of eyes [Annual]

Secondary Outcome Measures

1. Autorefraction [Annual]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sun Yat-sen University
• Australian National University

Investigators

• Study Director: Mingguang He, PhD, MD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00627874
• Other Study ID Numbers: PLS2008
• First Posted: Mar 4, 2008
• Last Update Posted: Feb 24, 2009
• Last Verified: Feb 1, 2009

• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Feb 24, 2009