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Completed

NCT Number: NCT02271373

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

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.

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Key information

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

increasing time spent outdoors

Behavioral

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study title

Development and Application of Appropriate Technology for Myopia Prevention and Control

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 22, 2014
Registry last updated
Oct 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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