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NCT02082743 Clinical Trial

Vision Care Intervention for Lower Grade School Children in Taiwan

Myopia Clinical Trial

Official title:
Intervention Program for Vision Care in Lower Grade Schoolchildren

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02082743
Other study ID # C1020515
Secondary ID HPA-MHW-C1020515
Status Completed
Phase N/A
First received February 23, 2014
Last updated August 5, 2015
Start date October 2013
Est. completion date February 2015

Study information
Verified date July 2015
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Ministry of Health and Welfare: Taiwan(R.O.C)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1020
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 7 Years
Eligibility Inclusion Criteria:

All the students in Grade 1

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Outdoor activity in recess time
Outdoor activity in recess time

Locations
Country Name City State
Taiwan Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine Kaohsiung

Sponsors (2)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital Ministry of Health and Welfare, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Other data from light meter recorder 1 week No
Other questionnaire 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 1 week No
Primary Cycloplegic refraction 1 year No
Secondary Axial length 1 year No
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