Vision Care Intervention for Lower Grade School Children in Taiwan

August 5, 2015 updated by: Chang Gung Memorial Hospital

Intervention Program for Vision Care in Lower Grade Schoolchildren

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1020

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All the students in Grade 1

Exclusion Criteria:

No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Outdoor activity
Outdoor activity in recess time
Behavioral: Outdoor activity in recess time
Outdoor activity in recess time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cycloplegic refraction
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Axial length
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
data from light meter recorder
Time Frame: 1 week
1 week
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

Ministry of Health and Welfare, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 23, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1020515
  • HPA-MHW-C1020515 (Other Grant/Funding Number: Health Promotion Administration, Ministry of Health and Welfare, Taiwan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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