Trial of Myopia Prevention Using +3D Lenses - Tabular View

Tracking Information

First Received Date ^ICMJE

February 20, 2008

Last Updated Date

February 20, 2009

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Axial Length of eyes [ Time Frame: Annual ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00627874 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Autorefraction [ Time Frame: Annual ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Trial of Myopia Prevention Using +3D Lenses

Official Title ^ICMJE

A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Myopia

Intervention ^ICMJE

Device: +3D Lenses

wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

Study Arms

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1200

Estimated Completion Date

April 2012

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00627874

Other Study ID Numbers ^ICMJE

PLS2008

Has Data Monitoring Committee

Responsible Party

Mingguang He, Zhongshan Ophthalmic Center, ZOC

Study Sponsor ^ICMJE

Sun Yat-sen University

Collaborators ^ICMJE

Australian National University

Investigators ^ICMJE

Study Director:

Mingguang He, PhD, MD

Zhongshan Ophthalmic Center

Information Provided By

Sun Yat-sen University

Verification Date

February 2009

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