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

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ClinicalTrials.gov Identifier: NCT00627874
Recruitment Status : Unknown
Verified February 2009 by Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : March 4, 2008
Last Update Posted : February 24, 2009
Sponsor:
Collaborator:
Information provided by:

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
Myopia Device: +3D Lenses

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  (Clinical Trial)
Estimated 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 : April 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 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 [ Time Frame: Annual ]

Secondary Outcome Measures :
  1. Autorefraction [ Time Frame: Annual ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627874


Sponsors and Collaborators
Sun Yat-sen University
Australian National University
Investigators
Study Director: Mingguang He, PhD, MD Zhongshan Ophthalmic Center, Sun Yet-sen University
More Information

Responsible Party: Mingguang He, Zhongshan Ophthalmic Center, ZOC
ClinicalTrials.gov Identifier: NCT00627874     History of Changes
Other Study ID Numbers: PLS2008
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases