Time Outdoors as an Intervention for Myopia in Children

NCT02980445 | Unknown DMC

• 1 other identifier: SHEH-M001
• Study Type: interventional
• Target: 7,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia

Keywords

Myopia; Outdoor time; Children; Intervention; Prevention

Outcome Measures

Primary Outcomes (1)

• Cycloplegic refractive power（auto-refractor instrument）

  The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)

  1 year

Secondary Outcomes (1)

• Axial length(IOL Master instrument)

  6 months

Study Arms (3)

Control

NO INTERVENTION

Outdoor Activity 1

EXPERIMENTAL

40min outdoor time in total.

Behavioral: Outdoor activity 1

Outdoor Activity 2

EXPERIMENTAL

80min outdoor time in total

Behavioral: Outdoor activity 2

Interventions

Outdoor activity 1 BEHAVIORAL

40-minute outdoor activity

Outdoor Activity 1

Outdoor activity 2 BEHAVIORAL

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

Outdoor Activity 2

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Brien Holden Vision: collaborator

Related Publications (3)

• 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.

  PMID: 37016357 DERIVED

• 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.

  PMID: 35882514 DERIVED

• 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.

  PMID: 35779695 DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Xun Xu, MD

  Shanghai Eye Disease Prevention and Treatment Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: December 2, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: May 1, 2019
• Last Updated: December 2, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share