The Impact of Bright Classroom on Myopia

Myopia Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05156190
• Other study ID #: Bright Classrooms-TP
• Secondary ID: light renovation
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2024
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Queen's University, Belfast	Affiliated Eye Hospital of Nanchang University, Clearly, MOH Foundation, Queen's University, State Key Laboratory of Subtropical Building Science, South China University of Technology (SCUT), The Eye Hospital of Wenzhou Medical University, Velux China, Zhongshan Ophthalmic Center, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years