Back to resultsTime Outdoors as an Intervention for Myopia in Children
Primary Purpose
Myopia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Outdoor activity 1
Outdoor activity 2
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring Myopia, Outdoor time, Children, Intervention, Prevention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
- Not suitable for inclusion in the study as deemed by the investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control
Outdoor Activity 1
Outdoor Activity 2
Arm Description
40min outdoor time in total.
80min outdoor time in total
Outcomes
Primary Outcome Measures
Cycloplegic refractive power（auto-refractor instrument）
The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
Secondary Outcome Measures
Axial length(IOL Master instrument)
The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).
Full Information
NCT ID
NCT02980445
First Posted
November 21, 2016
Last Updated
November 29, 2016
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Brien Holden Vision
1. Study Identification
Unique Protocol Identification Number
NCT02980445
Brief Title
Time Outdoors as an Intervention for Myopia in Children
Official Title
Time Outdoors as an Intervention for Myopia in Children--School-based Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Collaborators
Brien Holden Vision
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
To evaluate the effect of increased time outdoors on the incidence of myopia in non-myopic children;
To evaluate the effect of increased time outdoors on the progression of myopia in myopic children;
To explore if there is dose-response effect of time outdoors on the incidence and progression of myopia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia, Outdoor time, Children, Intervention, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Outdoor Activity 1
Arm Type
Experimental
Arm Description
40min outdoor time in total.
Arm Title
Outdoor Activity 2
Arm Type
Experimental
Arm Description
80min outdoor time in total
Intervention Type
Behavioral
Intervention Name(s)
Outdoor activity 1
Intervention Description
40-minute outdoor activity
Intervention Type
Behavioral
Intervention Name(s)
Outdoor activity 2
Intervention Description
Dose 1 plus an additional 40-minute outdoor activities during recesses
Primary Outcome Measure Information:
Title
Cycloplegic refractive power（auto-refractor instrument）
Description
The Cycloplegic refraction of all children are measured by auto-refractor(KR-8900, Topcon)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Axial length(IOL Master instrument)
Description
The axial length of the eyeball are measured by IOL Master(version 5.02, Carl Zeiss).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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).
Not suitable for inclusion in the study as deemed by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xun Xu, MD
Organizational Affiliation
Shanghai Eye Disease Prevention and Treatment Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35882514
Citation
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.
Results Reference
derived
PubMed Identifier
35779695
Citation
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.
Results Reference
derived
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Time Outdoors as an Intervention for Myopia in Children
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