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临床试验/NCT05728762
NCT05728762进行中(未招募)不适用

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

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,920 人开始时间: 2023年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,920
试验地点
1
主要终点
Cumulative incidence of myopia.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Schools without Grade 2 or Grade
  • 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.

研究组 & 干预措施

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.

干预措施: Novel LEDs (Device)

结局指标

主要结局

Cumulative incidence of myopia.

时间窗: 2 years

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.

次要结局

  • Change in axial length (AL, mm)(2 years)
  • Change in SER (D).(2 years)
  • Satisfaction with classroom lighting(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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