Guangzhou Outdoor Activity Longitudinal Study

This study is not yet open for participant recruitment.

Verified by Sun Yat-sen University, February 2009

First Received: February 19, 2009 No Changes Posted

Sponsors and Collaborators:	Sun Yat-sen University Australian National University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00848900

Purpose

The purpose of this study is to assess whether outdoor activities are effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

Condition	Intervention
Myopia	Behavioral: Outdoor activity

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Controlled Clinical Trial of the Effect of Increases Time Outdoors in the Prevention of Juvenile-Onset Myopia in Chinese Children

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

Primary Outcome Measures:

Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Refractive error [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Outdoor activity: Experimental Adding 1 hour outdoor time into school curricula	Behavioral: Outdoor activity Adding 1 hour outdoor time into school curricula
Control: No Intervention

Detailed Description:

To determine if increased engagement in outdoor activities reduces the development and progression of myopia in Chinese school children.
To identify the risk factors associated with the development and progression of juvenile-onset myopia.
To characterize the interaction between refractive error and education.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All the students in Grade 1

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848900

Contacts

Contact: Mingguang He, PhD, MD	(+8620)87330487	fan.xiang@anu.edu.au
Contact: Fan Xiang, MD	(+61)0401027116	fan.xiang@anu.edu.au

Locations

China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Sun Yat-sen University

Australian National University

Investigators

Principal Investigator:	Mingguang He, PhD, MD	Zhongshan Ophthalmic Center
Principal Investigator:	Ian Morgan, PhD	Australian National University

More Information

No publications provided

Responsible Party:	Zhongshan Ophthalmic Center, ZOC ( Mingguang He )
Study ID Numbers:	GOAL2009
Study First Received:	February 19, 2009
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00848900 History of Changes
Health Authority:	China: Ethics Committee

Study placed in the following topic categories:

Eye Diseases
Myopia
Refractive Errors

Additional relevant MeSH terms:

Eye Diseases
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on August 30, 2009