Time Outdoors as an Intervention for Myopia in Children

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02980445
• Other study ID #: SHEH-M001
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 21, 2016
• Last updated: November 29, 2016
• Start date: November 2016
• Est. completion date: May 2019

Study information

• Verified date: November 2016
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 7200
• Est. completion date: May 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Behavioral:
• Outdoor activity 1
40-minute outdoor activity
• Outdoor activity 2
Dose 1 plus an additional 40-minute outdoor activities during recesses

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center	Brien Holden Vision

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cycloplegic refractive power(auto-refractor instrument)	The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)	1 year	No
Secondary	Axial length(IOL Master instrument)	The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).	6 months	No