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Guangzhou Outdoor Activity Longitudinal Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00848900
First received: February 19, 2009
Last updated: November 19, 2010
Last verified: October 2010
History of Changes
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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:
  • Cycloplegic refraction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
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
No Intervention: Control
Experimental: Outdoor activity
Adding 1 hour outdoor time into school curricula
 Behavioral: Outdoor activity
Adding 1 hour outdoor time into school curricula

Detailed Description:
  1. To determine if increased engagement in outdoor activities reduces the development and progression of myopia in Chinese school children.
  2. To identify the risk factors associated with the development and progression of juvenile-onset myopia.
  3. 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:

  • No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848900

Locations
China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Mingguang He, PhD, MD Zhongshan Ophthalmic Center
  More Information

No publications provided

Responsible Party: Mingguang He, Zhongshan Ophthalmic Center, ZOC
ClinicalTrials.gov Identifier: NCT00848900     History of Changes
Other Study ID Numbers: GOAL2009
Study First Received: February 19, 2009
Last Updated: November 19, 2010
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013