Time Outdoors as an Intervention for Myopia in Children

Not Applicable

• Conditions: Myopia
• Interventions: Behavioral: Outdoor activity 2; Behavioral: Outdoor activity 1

• Registration Number: NCT02980445
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

The purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.

Detailed Description

1. To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;

2. To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;

3. To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-29
• Last Update Submitted: 2016-11-29
• Study First Posted: 2016-12-02
• Last Update Posted: 2016-12-02
• Primary Completion: 2018-11
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7200

Inclusion Criteria

1. at baseline be enrolled in grade 1 and 2 of primary schools;
2. have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent;
3. Children verbally consent when registration for examination

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Exclusion Criteria

1. Any systemic or ocular pathology that may affect the refractive error status of the eye;
2. Strabismus and amblyopia;
3. Intellectual disability;
4. Using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses).
5. Not suitable for inclusion in the study as deemed by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outdoor Activity 2	Outdoor activity 2	80min outdoor time in total
Outdoor Activity 1	Outdoor activity 1	40min outdoor time in total.

Primary Outcome Measures

Name	Time	Method
Cycloplegic refractive power（auto-refractor instrument）	1 year	The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)

Secondary Outcome Measures

Name	Time	Method
Axial length(IOL Master instrument)	6 months	The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).