Effect of Increasing Time Spent Outdoors on Myopia Prevention in School-Aged Children in Northeast China
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
increasing time spent outdoors
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Vision, Ocular, Physical activity, Schoolchildren, Intervention Studies
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
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.
The control school did not have any interventions.
Outcomes
Primary Outcome Measures
Changes in uncorrected visual acuity
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
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
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).
Full Information
NCT ID
NCT02271373
First Posted
October 19, 2014
Last Updated
October 22, 2014
Sponsor
Anhui Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02271373
Brief Title
Effect of Increasing Time Spent Outdoors on Myopia Prevention in School-Aged Children in Northeast China
Official Title
Development and Application of Appropriate Technology for Myopia Prevention and Control
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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 in northeast China.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Vision, Ocular, Physical activity, Schoolchildren, Intervention Studies
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
3521 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control school did not have any interventions.
Intervention Type
Behavioral
Intervention Name(s)
increasing time spent outdoors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in uncorrected visual acuity
Description
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.
Time Frame
Baseline, Month 6, Month 12
Secondary Outcome Measure Information:
Title
Questionnaire survey
Description
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.
Time Frame
Baseline
Title
Changes in ocular biometric parameters
Description
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).
Time Frame
Baseline, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangbiao Tao, PhD
Organizational Affiliation
Department of Maternal, Child and Maternal Health, School of Public Health, Anhui Medical University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26152123
Citation
Jin JX, Hua WJ, Jiang X, Wu XY, Yang JW, Gao GP, Fang Y, Pei CL, Wang S, Zhang JZ, Tao LM, Tao FB. Effect of outdoor activity on myopia onset and progression in school-aged children in northeast China: the Sujiatun Eye Care Study. BMC Ophthalmol. 2015 Jul 9;15:73. doi: 10.1186/s12886-015-0052-9.
Results Reference
derived
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Effect of Increasing Time Spent Outdoors on Myopia Prevention in School-Aged Children in Northeast China
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