Back to resultsVision Care Intervention for Lower Grade School Children in Taiwan
Primary Purpose
Myopia, Outdoor Activity, Policy of Recess Outside Classroom
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Outdoor activity in recess time
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Myopia, Outdoor activity, Recess outside classroom
Eligibility Criteria
Inclusion Criteria:
All the students in Grade 1
Exclusion Criteria:
No
Sites / Locations
- Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Outdoor activity
Control
Arm Description
Outdoor activity in recess time
Outcomes
Primary Outcome Measures
Cycloplegic refraction
Secondary Outcome Measures
Axial length
Full Information
NCT ID
NCT02082743
First Posted
February 23, 2014
Last Updated
August 5, 2015
Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02082743
Brief Title
Vision Care Intervention for Lower Grade School Children in Taiwan
Official Title
Intervention Program for Vision Care in Lower Grade Schoolchildren
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is making use of school policy- recess outside classroom (ROC7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Outdoor Activity, Policy of Recess Outside Classroom
Keywords
Myopia, Outdoor activity, Recess outside classroom
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1020 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outdoor activity
Arm Type
Experimental
Arm Description
Outdoor activity in recess time
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Outdoor activity in recess time
Intervention Description
Outdoor activity in recess time
Primary Outcome Measure Information:
Title
Cycloplegic refraction
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Axial length
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
data from light meter recorder
Time Frame
1 week
Title
questionnaire
Description
Children and their parents report how many hours per week in near work (such as reading, computer game, learning and practicing violin or piano) and outdoor activities
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the students in Grade 1
Exclusion Criteria:
No
Facility Information:
Facility Name
Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
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Vision Care Intervention for Lower Grade School Children in Taiwan
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