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

Myopia Clinical Trial

Official title:

Development and Application of Appropriate Technology for Myopia Prevention and Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271373
• Other study ID #: 2013001
• Status: Completed
• Phase: N/A
• First received: October 19, 2014
• Last updated: October 22, 2014
• Start date: November 2012
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3521
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Month 6, Month 12	No
Secondary	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.	Baseline	No
Secondary	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).	Baseline, Month 12	No