跳至主要内容
临床试验/NCT05594719
NCT05594719招募中不适用

The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow in School Students: a Randomized Controlled Trial

Shanghai Eye Disease Prevention and Treatment Center2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
2
主要终点
Retinal blood flow density after reading

研究概览

简要总结

In 2020, the overall myopia rate among children and adolescents was 52.7% in China. The COVID-19 pandemic has increased students' time of indoor eye-using, and it showed that the light exposure intensity of myopic students is lower than that of non-myopia students. Studies have found that in addition to exposure to light intensity, the occurrence and development of myopia is also related to the color temperature and wavelength band of light. The sun-like spectrum refers to the spectrum with continuous wavelength bands. Animal experiments suggest that sun-like artificial lighting can prevent myopia, but the relationship between sun-like artificial lighting with different color temperatures and myopia is unknown. Clinical trials suggest that artificial lighting with a sun-like spectrum can delay fundus blood flow decline. One hypothesis is that reduced choroidal blood flow leads to scleral hypoxia and promotes the development of myopia. This study aims at comparing the effects of sun-like spectrum artificial lighting with different dominant wavelengths on the human eye, and providing clues for the prevention and control of myopia.

详细描述

In 2018, eight departments including the Ministry of Education jointly issued the Implementation Plan for Comprehensive Prevention and Control of Myopia in Children and Adolescents. As of 2020, the overall myopia rate among children and adolescents was 52.7% in China. The COVID-19 pandemic has increased students' time of indoor eye-using, and it showed that the light exposure intensity of myopic students is lower than that of non-myopia students. Studies have found that in addition to exposure to light intensity, the occurrence and development of myopia is also related to the color temperature and wavelength band of light. Animal experiments showed that the bandwidth of light had a significant effect on the emmetropia of the eye, and white light can promote emmetropia more than monochromatic light; longer-wavelength light and shorter-wavelength light can promote and inhibit the development of myopia through hyperopia and myopic defocus, respectively. At present, the artificial lighting methods on the market are mainly light emitting diode (LED), whose light spectrum is discontinuous. With the advancement of related research and lighting technology, multiple LED emission peaks and "sun-like spectrum" desk lamps have gradually appeared. The sun-like spectrum refers to the spectrum with continuous wavelength bands. Animal experiments suggest that sun-like artificial lighting can prevent myopia, but the relationship between sun-like artificial lighting with different color temperatures and myopia is unknown. Clinical trials suggest that artificial lighting with a sun-like spectrum can delay fundus blood flow decline. Fundus blood flow is sensitive to myopia stimuli, and is a short-term effect indicator of the relationship between light environment and myopia. One hypothesis is that reduced choroidal blood flow leads to scleral hypoxia and promotes the development of myopia. Therefore, in this study fundus blood flow was selected as the main research indicator, aiming to compare the effects of sun-like spectrum artificial lighting with different dominant wavelengths on the human eye, and provide clues for the prevention and control of myopia.

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 (Participant)

盲法说明

The participants were randomly divided into three groups without knowing the type of light

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • School students aged from 7 to 15, regardless of sex or gender;
  • Diopter between -2.0D and 3.0D, and astigmatism not exceed 0.75D;
  • No organic disease and in good general condition;
  • Have obtained the consent of their parents or guardians, and can cooperate.

排除标准

  • Suffering from amblyopia, strabismus, color weakness, congenital cataract, glaucoma and other eye diseases;
  • Other circumstances judged by the investigator to be unsuitable to participate in the research.

结局指标

主要结局

Retinal blood flow density after reading

时间窗: At the timepoint after reading for 1 hour

Data werevcollected from Optovue AngioVue OCT (macular blood data collected), dominant eye examined

次要结局

  • Accommodation ability after reading(At the timepoint after reading for 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验