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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Autorefraction [ Time Frame: Annual ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627874

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

No publications provided

Responsible Party: Mingguang He, Zhongshan Ophthalmic Center, ZOC
ClinicalTrials.gov Identifier: NCT00627874     History of Changes
Other Study ID Numbers: PLS2008
Study First Received: February 20, 2008
Last Updated: February 20, 2009
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014