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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sun Yat-sen University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Australian National University
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00627874
First received: February 20, 2008
Last updated: February 20, 2009
Last verified: February 2009
History of Changes

February 20, 2008
February 20, 2009
April 2010
April 2012   (final data collection date for primary outcome measure)
Axial Length of eyes [ Time Frame: Annual ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00627874 on ClinicalTrials.gov Archive Site
Autorefraction [ Time Frame: Annual ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of Myopia Prevention Using +3D Lenses
A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children

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.
  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Myopia
Device: +3D Lenses
wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
  • Experimental: 1
    wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
    Intervention: Device: +3D Lenses
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1200
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Not Provided
Not Provided
 
NCT00627874
PLS2008
Not Provided
Mingguang He, Zhongshan Ophthalmic Center, ZOC
Sun Yat-sen University
Australian National University
Study Director: Mingguang He, PhD, MD Zhongshan Ophthalmic Center
Sun Yat-sen University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP