We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00627874
First Posted: March 4, 2008
Last Update Posted: February 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Australian National University
Information provided by:
Sun Yat-sen University
  Purpose
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 Intervention
Myopia Device: +3D Lenses

Study Type: Interventional
Study Design: 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

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Axial Length of eyes [ Time Frame: Annual ]

Secondary Outcome Measures:
  • Autorefraction [ Time Frame: Annual ]

Estimated Enrollment: 1200
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: February 20, 2008
First Posted: March 4, 2008
Last Update Posted: February 24, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases