The Impact of Bright Classroom on Myopia

NCT ID: NCT05156190

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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bright classrooms with skylight or renovated artificial light

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.

Group Type EXPERIMENTAL

bright classrooms with light level over 1000 lux

Intervention Type OTHER

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

conventional classrooms

Students will study in conventional classrooms with normal light level for three years and vision will be screened annual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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bright classrooms with light level over 1000 lux

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen's University

OTHER

Sponsor Role collaborator

Clearly

OTHER

Sponsor Role collaborator

Affiliated Eye Hospital of Nanchang University

OTHER

Sponsor Role collaborator

The Eye Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role collaborator

State Key Laboratory of Subtropical Building Science, South China University of Technology (SCUT)

UNKNOWN

Sponsor Role collaborator

MOH Foundation

UNKNOWN

Sponsor Role collaborator

Velux China

UNKNOWN

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role lead

Responsible Party

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Nathan Congdon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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light renovation

Identifier Type: OTHER

Identifier Source: secondary_id

Bright Classrooms-TP

Identifier Type: -

Identifier Source: org_study_id

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