Trial of Myopia Prevention Using +3D Lenses - Full Text View

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

This study is not yet open for participant recruitment.

Verified by Sun Yat-sen University, February 2009

First Received: February 20, 2008 Last Updated: February 20, 2009 History of Changes

Sponsor:	Sun Yat-sen University
Collaborator:	Australian National University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00627874

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 Control: Uncontrolled 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
1: Experimental 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
2: No Intervention

Detailed Description:

To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children.
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

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:	Zhongshan Ophthalmic Center, ZOC ( Mingguang He )
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 September 01, 2010