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Time Outdoors as an Intervention for Myopia in Children

Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02980445
Enrollment
7200
Registered
2016-12-02
Start date
2016-11-30
Completion date
2019-05-31
Last updated
2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Keywords

Myopia, Outdoor time, Children, Intervention, Prevention

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.

Interventions

BEHAVIORALOutdoor activity 1

40-minute outdoor activity

BEHAVIORALOutdoor activity 2

Dose 1 plus an additional 40-minute outdoor activities during recesses

Sponsors

Brien Holden Vision
CollaboratorINDUSTRY
Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Cycloplegic refractive power(auto-refractor instrument)1 yearThe Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)

Secondary

MeasureTime frameDescription
Axial length(IOL Master instrument)6 monthsThe axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026