Time Outdoors as an Intervention for Myopia in Children

Shanghai Eye Disease Prevention and Treatment Center

Status: Unknown

Conditions: Myopia

Treatments: Behavioral: Outdoor activity 2; Behavioral: Outdoor activity 1

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02980445

SHEH-M001

Details and patient eligibility

About

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

Full 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.

Enrollment: 7,200 estimated patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,200 participants in 3 patient groups

Control

No Intervention group

Outdoor Activity 1

Experimental group

Description:

40min outdoor time in total.

Treatment:

Behavioral: Outdoor activity 1

Outdoor Activity 2

Experimental group

Description:

80min outdoor time in total

Treatment:

Behavioral: Outdoor activity 2