Back to resultsGuangzhou Outdoor Activity Longitudinal Study
Primary Purpose
Myopia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Outdoor activity
Sponsored by
About this trial
This is an interventional prevention trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- All the students in Grade 1
Exclusion Criteria:
- No
Sites / Locations
- Zhongshan Ophthalmic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Outdoor activity
Arm Description
Adding 1 hour outdoor time into school curricula
Outcomes
Primary Outcome Measures
Cycloplegic refraction
Secondary Outcome Measures
Visual acuity
Full Information
NCT ID
NCT00848900
First Posted
February 19, 2009
Last Updated
November 19, 2010
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT00848900
Brief Title
Guangzhou Outdoor Activity Longitudinal Study
Official Title
A Controlled Clinical Trial of the Effect of Increases Time Outdoors in the Prevention of Juvenile-onset Myopia in Chinese Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Outdoor activity
Arm Type
Experimental
Arm Description
Adding 1 hour outdoor time into school curricula
Intervention Type
Behavioral
Intervention Name(s)
Outdoor activity
Intervention Description
Adding 1 hour outdoor time into school curricula
Primary Outcome Measure Information:
Title
Cycloplegic refraction
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the students in Grade 1
Exclusion Criteria:
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingguang He, PhD, MD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26372583
Citation
He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015 Sep 15;314(11):1142-8. doi: 10.1001/jama.2015.10803.
Results Reference
derived
PubMed Identifier
25811755
Citation
Zhou Z, Morgan IG, Chen Q, Jin L, He M, Congdon N. Disordered sleep and myopia risk among Chinese children. PLoS One. 2015 Mar 26;10(3):e0121796. doi: 10.1371/journal.pone.0121796. eCollection 2015.
Results Reference
derived
Learn more about this trial
Guangzhou Outdoor Activity Longitudinal Study
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