Time Outdoors as an Intervention for Myopia in Children

November 29, 2016 updated by: Shanghai Eye Disease Prevention and Treatment Center

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

The purpose of this study is to determine whether improved outdoor time has an effect on the onset and progression of myopia in children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

7200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cycloplegic refractive power（auto-refractor instrument）
Time Frame: 1 year
The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

Brien Holden Vision

Investigators

  • Principal Investigator: Xun Xu, MD, Shanghai Eye Disease Prevention and Treatment Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

December 2, 2016

Study Record Updates

Last Update Posted (Estimate)

December 2, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEH-M001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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