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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
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Myopia focused on measuring bright classroom, myopia, RCT, China

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

    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
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    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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