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

Primary Purpose

Myopia, Refractive Errors, Eye Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Novel LEDs
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Regular LEDs

Novel LEDs

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
Satisfaction with classroom lighting
Subjects are asked to complete a questionnaire to evaluate their satisfaction with classroom lighting during the study period.

Full Information

First Posted
February 5, 2023
Last Updated
February 17, 2023
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05728762
Brief Title
Light Emitting Diodes With a Continuous Spectrum of 430-780nm for Myopia Prevention
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 27, 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Refractive Errors, Eye Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1920 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regular LEDs
Arm Type
No Intervention
Arm Description
Students will accept regular LEDs with a spectrum of 430-630 nm for lighting in the classroom.
Arm Title
Novel LEDs
Arm Type
Experimental
Arm Description
Students will accept novel LEDs with a spectrum of 430-780 nm for lighting in the classroom.
Intervention Type
Device
Intervention Name(s)
Novel LEDs
Intervention Description
LEDs with a continuous spectrum of 430-780 nm.
Primary Outcome Measure Information:
Title
Cumulative incidence of myopia.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in SER (D).
Description
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).
Time Frame
2 years
Title
Change in axial length (AL, mm)
Description
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).
Time Frame
2 years
Title
Satisfaction with classroom lighting
Description
Subjects are asked to complete a questionnaire to evaluate their satisfaction with classroom lighting during the study period.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Change in corneal curvature (mm)
Description
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).
Time Frame
2 years
Title
Change in anterior chamber depth (mm)
Description
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).
Time Frame
2 years
Title
Change in lens thickness (mm)
Description
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).
Time Frame
2 years
Title
Change in choroidal thickness (μm)
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yizhi Liu
Phone
+86-020-6686986
Email
yzliu62@yahoo.com
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu
Phone
+86-020-6686986
Email
yzliu62@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yizhi Liu
First Name & Middle Initial & Last Name & Degree
Yangfa Zeng

12. IPD Sharing Statement

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

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