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

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ClinicalTrials.gov Identifier: NCT02271373
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Fangbiao Tao, Anhui Medical University

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.

Condition or disease Intervention/treatment Phase
Myopia Behavioral: increasing time spent outdoors Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2014

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.



Primary Outcome Measures :
  1. Changes in uncorrected visual acuity [ Time Frame: 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 :
  1. Questionnaire survey [ Time Frame: 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.

  2. Changes in ocular biometric parameters [ Time Frame: 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).



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271373


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fangbiao Tao, Dean of School of Public Health, Anhui Medical University, Anhui Medical University
ClinicalTrials.gov Identifier: NCT02271373     History of Changes
Other Study ID Numbers: 2013001
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014

Keywords provided by Fangbiao Tao, Anhui Medical University:
Vision, Ocular
Physical activity
Schoolchildren
Intervention Studies

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases