The Impact of Bright Classroom on Myopia

NCT05156190 | Withdrawn

• 2 other identifiers: Bright Classrooms-TPlight renovation
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myopia

Keywords

bright classroom, myopia, RCT, China

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

bright classrooms with skylight or renovated artificial light

EXPERIMENTAL

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.

Other: bright classrooms with light level over 1000 lux

conventional classrooms

NO INTERVENTION

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

Interventions

bright classrooms with light level over 1000 lux 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

bright classrooms with skylight or renovated artificial light

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Willingness of parents to give consent
• Membership in randomly-selected classes at the selected schools.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: December 14, 2021
• Study Start: June 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share