NCT05728762

Brief Summary

The purpose of this clinical trial is to evaluate the effect of light-emitting diodes (LEDs) with a continuous spectrum of 430-780 nm for lighting in the classroom on myopia prevention among children in Grades 2 and 3.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,920

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 22, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

February 5, 2023

Last Update Submit

March 4, 2024

Conditions

MyopiaRefractive ErrorsEye Diseases

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of myopia.

    Myopia is defined as a cycloplegic spherical equivalent refraction (SER) of at least -0.5 D. Incident myopia was defined as myopia detected in children who did not have myopia at baseline.

    2 years

Secondary Outcomes (3)

  • Change in SER (D).

    2 years

  • Change in axial length (AL, mm)

    2 years

  • Satisfaction with classroom lighting

    2 years

Other Outcomes (4)

  • Change in corneal curvature (mm)

    2 years

  • Change in anterior chamber depth (mm)

    2 years

  • Change in lens thickness (mm)

    2 years

  • +1 more other outcomes

Study Arms (2)

Regular LEDs

NO INTERVENTION

Students will accept regular LEDs with a spectrum of 430-630 nm for lighting in the classroom.

Novel LEDs

EXPERIMENTAL

Students will accept novel LEDs with a spectrum of 430-780 nm for lighting in the classroom.

Device: Novel LEDs

Interventions

Novel LEDsDEVICE

LEDs with a continuous spectrum of 430-780 nm.

Novel LEDs

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All the students in Grades 2 and 3 from the 8 schools participated in a myopia surveillance program in Zengcheng District, Guangzhou, China.
  • Provision of consent and able to participate in all required activities of the study.

You may not qualify if:

  • Schools without Grade 2 or Grade 3.
  • Schools that only had one class in either grade.
  • Children who refused to accept cycloplegia and/or other examinations.
  • Children with ocular abnormalities and/or previous history of ocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

MyopiaRefractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 15, 2023

Study Start

February 22, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

CN(1)