Effect of Increasing Time Spent Outdoors on Myopia Prevention in School-Aged Children in Northeast China

Sponsor

Anhui Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02271373

Collaborator

(none)

3,521

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Myopia	Behavioral: increasing time spent outdoors	N/A

Detailed Description

The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors among elementary and secondary school students in northeast China. It is expected that the results will provide evidences for policy-makers and school healthcare providers for their school children myopia prevention.

Study Design

Study Type:

Interventional

Actual Enrollment :

3521 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Development and Application of Appropriate Technology for Myopia Prevention and Control

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Nov 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.	Behavioral: increasing time spent outdoors The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.
No Intervention: control group The control school did not have any interventions.

Arm

Intervention/Treatment

Experimental: intervention group

The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.

Behavioral: increasing time spent outdoors

No Intervention: control group

The control school did not have any interventions.

Outcome Measures

Primary Outcome Measures

Changes in uncorrected visual acuity [Baseline, Month 6, Month 12]
Uncorrected visual acuity (UCVA) was measured for the right eye, then the left eye, with a E Standard Logarithm Vision Acuity Chart (GB11533-2011) in 5-grade notation (5- LogMAR), with illumination of the chart around 500lx. If one of the eyes UCVA was less than 5.0, then tests with combined lenses were conducted among the poor eye-sighted for confirming the types of ametropia (normal, myopia, hyperopia or other eye diseases)．All the measurements were recorded.

Secondary Outcome Measures

Questionnaire survey [Baseline]
The parents and children underwent an interview together. The questionnaire included questions on children's gender, ethnicity, region of habitation; questions on parental education level, the monthly family income and whether the parents were myopic or not;. The interview also included questions on the amount of time spent for learning (reading or writing), screen time (television, computer, etc) and time spent outdoors after school in recent 7 days.
Changes in ocular biometric parameters [Baseline, Month 12]
A random subsample (12.8%) underwent cycloplegia. After ensuring that there was no risk for a medical mydriasis, cycloplegia was performed at baseline and intervention after 1 year in the Shenyang Aier Ophthalmology Hospital, respectively. Ocular biometric parameters (axial length, corneal curvature, anterior chamber depth and IOP) were measured in both eyes of all participants. Axial length, corneal curvature and anterior chamber depth were measured with IOL Master (intraoeular len master, IOL. Master) (Carl Zeiss Meditex, Jena, Germany); Intraocular pressure (IOP) measurement was obtained using a non-contact tonometry (NT-510, NIDEK, Gamagori, Japan). Cycloplegia was achieved by 0.5% tropicamide eye drops. Six drops of tropicamide 0.5% were administered at 5-minute intervals for both eyes. Refractometry was performed 20 minutes after the last cycle of cycloplegic eye drops by retinoscopy (YZ-24, Suzhou, China).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Grade of 1 to 5 in elementary schools and grade of 7 to 8 in secondary schools.

Exclusion Criteria:

Visual defect or other eye diseases; wearing orthokeratology; refractive surgery history.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Anhui Medical University

Investigators

Study Director: Fangbiao Tao, PhD, Department of Maternal, Child and Maternal Health, School of Public Health, Anhui Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fangbiao Tao, Dean of School of Public Health, Anhui Medical University, Anhui Medical University

ClinicalTrials.gov Identifier:

NCT02271373

Other Study ID Numbers:

2013001

First Posted:

Oct 22, 2014

Last Update Posted:

Oct 23, 2014

Last Verified:

Oct 1, 2014

Keywords provided by Fangbiao Tao, Dean of School of Public Health, Anhui Medical University, Anhui Medical University

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Oct 23, 2014