NCT02980445UnknownNot Applicable
Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study
Shanghai Eye Disease Prevention and Treatment Center0 sites7,200 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 7,200
- Primary Endpoint
- Cycloplegic refractive power（auto-refractor instrument）
Study Overview
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
- To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;
- To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;
- To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •at baseline be enrolled in grade 1 and 2 of primary schools;
- •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;
- •Children verbally consent when registration for examination
Exclusion Criteria
- •Any systemic or ocular pathology that may affect the refractive error status of the eye;
- •Strabismus and amblyopia;
- •Intellectual disability;
- •Using any anti-myopia treatments (orthokeratology, atropine, accommodation function training, acupuncture, auricular point sticking, progressive addition spectacle lenses or other anti-myopia contact lenses).
- •Not suitable for inclusion in the study as deemed by the investigator.
Arms & Interventions
Control
No Intervention
Outdoor Activity 1
Experimental
40min outdoor time in total.
Intervention: Outdoor activity 1 (Behavioral)
Outdoor Activity 2
Experimental
80min outdoor time in total
Intervention: Outdoor activity 2 (Behavioral)
Outcomes
Primary Outcomes
Cycloplegic refractive power（auto-refractor instrument）
Time Frame: 1 year
The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
Secondary Outcomes
- Axial length(IOL Master instrument)(6 months)
Investigators
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