Vision Care Intervention for Lower Grade School Children... | NCT02082743

Studies
Vision Care Intervention for Lower Grade School Children in Taiwan

NCT02082743

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Aug 7, 2015Estimated

Enrollment

1,020Actual

Phase

Not Applicable

Conditions

Myopia
Outdoor Activity
Policy of Recess Outside Classroom

Interventions

Outdoor activity in recess time

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HPA-MHW-C1020515	Other Grant/Funding Number	Health Promotion Administration, Ministry of Health and Welfare, Taiwan

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Feb 23, 2014

First Submission Date that Met QC Criteria

Mar 6, 2014

First Posted Date

Mar 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2015

Last Update Posted Date

Aug 7, 2015Estimated

Name	Class
Ministry of Health and Welfare, Taiwan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,020Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Outdoor activity	Experimental	Outdoor activity in recess time	Behavioral: Outdoor activity in recess time
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Outdoor activity in recess time	Behavioral	Outdoor activity in recess time	Outdoor activity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cycloplegic refraction		1 year

Secondary Outcomes

Measure	Description	Time Frame
Axial length		1 year

Other Outcomes

Measure	Description	Time Frame
data from light meter recorder		1 week
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All the students in Grade 1

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine		Kaohsiung City			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided