Light Emitting Diodes With a Continuous Spectrum of 430-780nm for Myopia Prevention

Effect of Light Emitting Diodes With a Continuous Spectrum of 430-780nm Used in the Classroom on Myopia Prevention Among School-Aged Children: A Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Eye Diseases; Refractive Errors; Myopia
• Intervention / Treatment: Device: Novel LEDs

Detailed Description

Myopia is a common condition that primarily arises in childhood and remains the most important cause of vision loss for children. Irreversible vision-threatening ocular complications such as posterior staphyloma, myopic maculopathy, and glaucoma may occur with a dramatically high risk once myopia progresses to high myopia. Considering the striking rapid increases in the prevalence of myopia and the premature age of myopia onset, myopia prevention is of extreme urgency and presents several challenges.

It has been proven with solid evidence that outdoor times has effects on myopia prevention, which may be attributed to outdoor light exposure. However, it is difficult to meet the required outdoor times (i.e., at least 2 hours/day) for school-aged children under such educational pressure, especially in China. The differences between the light outdoors and indoors in terms of the light spectrum provide some insights into research to find the alternative. The growth rate of the vitreous cavity in juvenile and adult tree shrews grown under red light with a wavelength of 628±10 nm was significantly slower than those grown under the normal fluorescent lighting group, and red light could induce a hyperopic shift in juvenile tree shrews, thus slowing down the development of myopia. Another experiment has also shown that the use of full-spectrum LED covering a continuous spectrum of 400-775 nm accelerated the recovery from form-deprivation myopia in chickens, and it is hypothesized that full-spectrum lighting may affect the choroid-scleral remodeling pathway, which is thought to be associated with myopia control.

The purpose of this study is to evaluate the effects of LEDs covering a continuous spectrum of 430-780 nm for lighting in the classroom (intervention arm) among students in Grades 2 and 3 compared with regular LEDs with a spectrum of 430-630 nm (control arm). Cluster randomization by class was chosen, and all classes in the same school and grade were equally and randomly assigned to the intervention or control arm, with follow-ups at 1- and 2-year. Vision acuity, ocular biometry, cycloplegic refraction, slit-lamp examinations, optical coherence tomography, optical coherence tomography angiography, and questionnaires will be performed at baseline and during the follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 1920
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular LEDs; Students will accept regular LEDs with a spectrum of 430-630 nm for lighting in the classroom.
Experimental: Novel LEDs; Students will accept novel LEDs with a spectrum of 430-780 nm for lighting in the classroom.	Device: Novel LEDs; LEDs with a continuous spectrum of 430-780 nm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in SER (D).	Change in cycloplegic SER (D) is characterized as the difference between the designed follow-up visit and baseline value. Refraction is performed with an autorefractor following full cycloplegia. The SER is calculated as the spherical power (D) plus half of the cylindrical power (D).	2 years
Change in axial length (AL, mm)	AL change (mm) is characterized as the difference between the designed follow-up visit and baseline value. The IOLMaster is used to measure AL (mm).	2 years
Satisfaction with classroom lighting	Subjects are asked to complete a questionnaire to evaluate their satisfaction with classroom lighting during the study period.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in corneal curvature (mm)	Corneal curvature change (mm) is characterized as the difference between the designed follow-up visit and baseline value. The IOLMaster is used to measure corneal curvature (mm).	2 years
Change in anterior chamber depth (mm)	Anterior chamber depth change (mm) is characterized as the difference between the designed follow-up visit and baseline value. The IOLMaster is used to measure anterior chamber depth (mm).	2 years
Change in lens thickness (mm)	Lens thickness change (mm) is characterized as the difference between the designed follow-up visit and baseline value. The IOLMaster is used to measure lens thickness (mm).	2 years
Change in choroidal thickness (μm)	Choroidal thickness change (μm) is characterized as the difference between the designed follow-up visit and baseline value. Optical coherence tomography is used to measure choroidal thickness.	2 years

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 5, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Refractive Errors; Eye Diseases; Myopia
• Other Study ID Numbers: 2022KYPJ192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No