Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Time Outdoors as an Intervention for Myopia in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02980445
Recruitment Status : Unknown
Verified November 2016 by Shanghai Eye Disease Prevention and Treatment Center.
Recruitment status was:  Enrolling by invitation
First Posted : December 2, 2016
Last Update Posted : December 2, 2016
Sponsor:
Collaborator:
Brien Holden Vision
Information provided by (Responsible Party):
Shanghai Eye Disease Prevention and Treatment Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Myopia Behavioral: Outdoor activity 1 Behavioral: Outdoor activity 2 Not Applicable

Detailed 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Control
Experimental: Outdoor Activity 1
40min outdoor time in total.
 Behavioral: Outdoor activity 1
40-minute outdoor activity
Experimental: Outdoor Activity 2
80min outdoor time in total
 Behavioral: Outdoor activity 2
Dose 1 plus an additional 40-minute outdoor activities during recesses


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cycloplegic refractive power（auto-refractor instrument） [ Time Frame: 1 year ]
    The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)


Secondary Outcome Measures :
  1. Axial length(IOL Master instrument) [ Time Frame: 6 months ]
    The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980445


Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Brien Holden Vision
Investigators
Layout table for investigator information
Principal Investigator: Xun Xu, MD Shanghai Eye Disease Prevention and Treatment Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT02980445    
Other Study ID Numbers: SHEH-M001
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: December 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shanghai Eye Disease Prevention and Treatment Center:
Myopia
Outdoor time
Children
Intervention
Prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Myopia
Refractive Errors
Eye Diseases