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CompletedNCT02271373Updated Oct 23, 2014

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

An interventional study of increasing time spent outdoors in Myopia, sponsored by Anhui Medical University. Completed. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2014-10-23.

Sponsored by Anhui Medical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
3,521
Allocation
Non-randomized
Ages
6 Years to 14 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Myopia

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Keywords

  • Vision, Ocular
  • Physical activity
  • Schoolchildren
  • Intervention Studies
03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 3,521 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Anhui Medical University is the lead sponsor of 102 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
3,521 participants (actual)

Study arms

  • 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.

Interventions

  • Behavioralincreasing 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Month 6, Month 12

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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).

    Time frame: Baseline, Month 12

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26152123 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02271373
Lead sponsor
Anhui Medical University
Responsible party
Fangbiao Tao (Dean of School of Public Health, Anhui Medical University, Anhui Medical University) — Principal investigator
First posted
Oct 22, 2014
Start date
Nov 2012
Primary completion
Nov 2013
Completion
Feb 2014
Last update
Oct 23, 2014

Study contacts

Fangbiao Tao, PhD
study director · Department of Maternal, Child and Maternal Health, School of Public Health, Anhui Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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