NCT00848900

Brief Summary

The purpose of this study is to assess whether outdoor activities are effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 22, 2010

Status Verified

October 1, 2010

Enrollment Period

3 years

First QC Date

February 19, 2009

Last Update Submit

November 19, 2010

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Cycloplegic refraction

    1 year

Secondary Outcomes (1)

  • Visual acuity

    6 months

Study Arms (2)

Control

NO INTERVENTION

Outdoor activity

EXPERIMENTAL

Adding 1 hour outdoor time into school curricula

Behavioral: Outdoor activity

Interventions

Outdoor activityBEHAVIORAL

Adding 1 hour outdoor time into school curricula

Outdoor activity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All the students in Grade 1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

  • He M, Xiang F, Zeng Y, Mai J, Chen Q, Zhang J, Smith W, Rose K, Morgan IG. Effect of Time Spent Outdoors at School on the Development of Myopia Among Children in China: A Randomized Clinical Trial. JAMA. 2015 Sep 15;314(11):1142-8. doi: 10.1001/jama.2015.10803.

    PMID: 26372583DERIVED

  • Zhou Z, Morgan IG, Chen Q, Jin L, He M, Congdon N. Disordered sleep and myopia risk among Chinese children. PLoS One. 2015 Mar 26;10(3):e0121796. doi: 10.1371/journal.pone.0121796. eCollection 2015.

    PMID: 25811755DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Mingguang He, PhD, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

November 22, 2010

Record last verified: 2010-10

Locations

CN(1)