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Vision Care Intervention for Lower Grade School Children in Taiwan

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ClinicalTrials.gov Identifier: NCT02082743
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : August 7, 2015
Sponsor:
Collaborator:
Ministry of Health and Welfare, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Myopia Outdoor Activity Policy of Recess Outside Classroom Behavioral: Outdoor activity in recess time Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention Program for Vision Care in Lower Grade Schoolchildren
Study Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Outdoor activity
Outdoor activity in recess time
Behavioral: Outdoor activity in recess time
Outdoor activity in recess time

No Intervention: Control



Primary Outcome Measures :
  1. Cycloplegic refraction [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Axial length [ Time Frame: 1 year ]

Other Outcome Measures:
  1. data from light meter recorder [ Time Frame: 1 week ]
  2. questionnaire [ Time Frame: 1 week ]
    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



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Ages Eligible for Study:   6 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All the students in Grade 1

Exclusion Criteria:

No


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082743


Locations
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Taiwan
Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine
Kaohsiung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Ministry of Health and Welfare, Taiwan
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02082743    
Other Study ID Numbers: C1020515
HPA-MHW-C1020515 ( Other Grant/Funding Number: Health Promotion Administration, Ministry of Health and Welfare, Taiwan )
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: July 2015
Keywords provided by Chang Gung Memorial Hospital:
Myopia
Outdoor activity
Recess outside classroom
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases