The Impact of Bright Classroom on Myopia (IMPACT)
Primary Purpose
Myopia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bright classrooms with light level over 1000 lux
Sponsored by
About this trial
This is an interventional basic science trial for Myopia focused on measuring bright classroom, myopia, RCT, China
Eligibility Criteria
Inclusion Criteria:
- Willingness of parents to give consent
- Membership in randomly-selected classes at the selected schools.
Exclusion Criteria:
- Children without consent from their parents will be excluded.
- Children having myopia (myopic spherical equivalent refractive error of <= -0.5D in one or both eyes) at baseline are excluded from the primary analysis, although they will be included in the secondary analyses, so there will be no need to exclude them from continuing to study with their classmates and use the assigned classroom.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
bright classrooms with skylight or renovated artificial light
conventional classrooms
Arm Description
Students will study in bright classrooms with either skylight or renovated artificial light with light level of over 1000 lux on school time for three years and vision will be screened annually.
Students will study in conventional classrooms with normal light level for three years and vision will be screened annual.
Outcomes
Primary Outcome Measures
three-year cumulative incidence of myopia
Three-year cumulative incidence of myopia in the Intervention and Control groups (intermediate incidence at one year will also be measured), defined as spherical equivalent (sphere + ½ cylinder) <= -0.5D in either eye, based on the definition used in the Refractive Error Study in Children.
Secondary Outcome Measures
Full Information
NCT ID
NCT05156190
First Posted
September 9, 2021
Last Updated
December 8, 2021
Sponsor
Queen's University, Belfast
Collaborators
Queen's University, Clearly, Affiliated Eye Hospital of Nanchang University, The Eye Hospital of Wenzhou Medical University, Zhongshan Ophthalmic Center, Sun Yat-sen University, State Key Laboratory of Subtropical Building Science, South China University of Technology (SCUT), MOH Foundation, Velux China
1. Study Identification
Unique Protocol Identification Number
NCT05156190
Brief Title
The Impact of Bright Classroom on Myopia
Acronym
IMPACT
Official Title
Cluster-randomized Trial of a Novel Bright Classroom and Artificial Light Renovation in the Prevention of Myopia Among Chinese School-going Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Queen's University, Clearly, Affiliated Eye Hospital of Nanchang University, The Eye Hospital of Wenzhou Medical University, Zhongshan Ophthalmic Center, Sun Yat-sen University, State Key Laboratory of Subtropical Building Science, South China University of Technology (SCUT), MOH Foundation, Velux China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This trial aims to test the effectiveness and practicality of study in the Bright Classrooms with skylight and artificial light renovation in reducing incident myopia in Chinese primary school children over three years, as compared to children studying in conventional classrooms.
Detailed Description
The investigators now propose a cluster-randomized controlled trial of Bright Classrooms to provide a definitive answer as to their effect on the reduction of myopia incidence with the interventions of students studying in bright classroom from skylight and artificial light renovation. The bright classroom trial will be conducted in Jiangxi Province, South-east China via Nanchang University Affiliated Eye Hospital and the artificial light renovation study will be in Zhejiang Province via Eye Hospital, Wenzhou Medical University. Classroom design and build will be supported by leading firm in this space, Velux. If the principal can be proven that such innovative architectural modifications and classroom light renovation successfully prevent myopia, it will provide an evidence-based justification for a broad variety of low-cost retrofits, new build designs and light renovation appropriate for various Chinese settings. These might include larger windows, skylights, artificial lighting and appropriate seating arrangements. Once in place, such architectural and light interventions could benefit children over many years, without extensive and difficult-to-sustain programs of behaviour change. This proof-of-principle project could address a significant global eye health challenge and have significant and sustainable socio-economic impact for China and built environments elsewhere throughout the world.
Schools selected for the trial are: Yifen County: 2 schools, Lichuan County: 2 schools, Yiyang County: 2 schools, Fuliang County: 1 school and Shanggao County: 1 school.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
bright classroom, myopia, RCT, China
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
3200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bright classrooms with skylight or renovated artificial light
Arm Type
Experimental
Arm Description
Students will study in bright classrooms with either skylight or renovated artificial light with light level of over 1000 lux on school time for three years and vision will be screened annually.
Arm Title
conventional classrooms
Arm Type
No Intervention
Arm Description
Students will study in conventional classrooms with normal light level for three years and vision will be screened annual.
Intervention Type
Other
Intervention Name(s)
bright classrooms with light level over 1000 lux
Intervention Description
Grade 2 primary school students at the intervention groups will study in bright classrooms for three years and incidence of myopia will be compared with those in conventional classrooms
Primary Outcome Measure Information:
Title
three-year cumulative incidence of myopia
Description
Three-year cumulative incidence of myopia in the Intervention and Control groups (intermediate incidence at one year will also be measured), defined as spherical equivalent (sphere + ½ cylinder) <= -0.5D in either eye, based on the definition used in the Refractive Error Study in Children.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willingness of parents to give consent
Membership in randomly-selected classes at the selected schools.
Exclusion Criteria:
Children without consent from their parents will be excluded.
Children having myopia (myopic spherical equivalent refractive error of <= -0.5D in one or both eyes) at baseline are excluded from the primary analysis, although they will be included in the secondary analyses, so there will be no need to exclude them from continuing to study with their classmates and use the assigned classroom.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
study subjects will be presented by code, and shared with other researchers
Learn more about this trial
The Impact of Bright Classroom on Myopia
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