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Time Outdoors as an Intervention for Myopia in Children

NCT ID: NCT02980445

Last Updated: 2016-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-05-31

Brief Summary

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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

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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.

Conditions

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Myopia

Keywords

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Myopia Outdoor time Children Intervention Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Outdoor Activity 1

40min outdoor time in total.

Group Type EXPERIMENTAL

Outdoor activity 1

Intervention Type BEHAVIORAL

40-minute outdoor activity

Outdoor Activity 2

80min outdoor time in total

Group Type EXPERIMENTAL

Outdoor activity 2

Intervention Type BEHAVIORAL

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

Interventions

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Outdoor activity 1

40-minute outdoor activity

Intervention Type BEHAVIORAL

Outdoor activity 2

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brien Holden Vision

INDUSTRY

Sponsor Role collaborator

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xun Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Eye Disease Prevention and Treatment Center

References

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Wang J, Sankaridurg P, Naduvilath T, Li W, Morgan IG, Rose KA, Weng R, Xu X, He X. Time outdoors positively associates with academic performance: a school-based study with objective monitoring of outdoor time. BMC Public Health. 2023 Apr 4;23(1):645. doi: 10.1186/s12889-023-15532-y.

Reference Type DERIVED
PMID: 37016357 (View on PubMed)

Gong W, Cheng T, Wang J, Zhang B, Chen J, Zhu J, Zou H, Liu K, He X, Xu X. Role of corneal radius of curvature in early identification of fundus tessellation in children with low myopia. Br J Ophthalmol. 2023 Oct;107(10):1532-1537. doi: 10.1136/bjo-2022-321295. Epub 2022 Jul 26.

Reference Type DERIVED
PMID: 35882514 (View on PubMed)

He X, Sankaridurg P, Wang J, Chen J, Naduvilath T, He M, Zhu Z, Li W, Morgan IG, Xiong S, Zhu J, Zou H, Rose KA, Zhang B, Weng R, Resnikoff S, Xu X. Time Outdoors in Reducing Myopia: A School-Based Cluster Randomized Trial with Objective Monitoring of Outdoor Time and Light Intensity. Ophthalmology. 2022 Nov;129(11):1245-1254. doi: 10.1016/j.ophtha.2022.06.024. Epub 2022 Jun 30.

Reference Type DERIVED
PMID: 35779695 (View on PubMed)

Other Identifiers

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SHEH-M001

Identifier Type: -

Identifier Source: org_study_id