The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Shorter-wavelength dominant light; Device: Light similar to the solar spectrum proportion; Device: Longer-wavelength dominant light

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangui He, PhD; Phone Number: 021-62717733; Email: xianhezi@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Xiangui He
      • Contact: Xiangui He, MD; Phone Number: +8615000755422; Email: xianhezi@163.com
    • Shanghai, Shanghai, China, 200041
      • Recruiting
      • Shanghai Eye Disease Prevention and Treatment Center
      • Contact: Xiangui He; Phone Number: 021-62717733

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light group 1; Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant;	Device: Shorter-wavelength dominant light; Shorter-wavelength dominant light
Placebo Comparator: Light group 2; Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight	Device: Light similar to the solar spectrum proportion; Light similar to the solar spectrum proportion with no specific wavelength dominant
Experimental: Light group 3; Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.	Device: Shorter-wavelength dominant light; Shorter-wavelength dominant light; Device: Longer-wavelength dominant light; Longer-wavelength dominant light

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal blood flow density after reading	Data werevcollected from Optovue AngioVue OCT (macular blood data collected), dominant eye examined	At the timepoint after reading for 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accommodation ability after reading	Data were collected from AcomoREF2 (AMF mode, record distance and high-frequency component), for the dominant eye. And the Accommodative response value was documented for further analysis.	At the timepoint after reading for 1 hour

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Principal Investigator: Xiangui He, PhD, Shanghai Eye Hospital

Publications and helpful links

General Publications

• Mirhajianmoghadam H, Pina A, Ostrin LA. Objective and Subjective Behavioral Measures in Myopic and Non-Myopic Children During the COVID-19 Pandemic. Transl Vis Sci Technol. 2021 Sep 1;10(11):4. doi: 10.1167/tvst.10.11.4.
• Muralidharan AR, Lanca C, Biswas S, Barathi VA, Wan Yu Shermaine L, Seang-Mei S, Milea D, Najjar RP. Light and myopia: from epidemiological studies to neurobiological mechanisms. Ther Adv Ophthalmol. 2021 Dec 19;13:25158414211059246. doi: 10.1177/25158414211059246. eCollection 2021 Jan-Dec.
• Rucker F. Monochromatic and white light and the regulation of eye growth. Exp Eye Res. 2019 Jul;184:172-182. doi: 10.1016/j.exer.2019.04.020. Epub 2019 Apr 21.
• Baeza Moyano D, González-Lezcano RA. Pandemic of Childhood Myopia. Could New Indoor LED Lighting Be Part of the Solution? Energies. 2021;14(13):3827. doi:10.3390/en14133827
• 陈军, 陈友三, 王菁菁, et al. 类太阳光谱LED照明对儿童青少年视网膜血流灌注影响的随机对照临床试验. zgxxws. 2022;43(3):338-340. doi:10.16835/j.cnki.1000-9817.2022.03.005
• Liu Y, Wang L, Xu Y, Pang Z, Mu G. The influence of the choroid on the onset and development of myopia: from perspectives of choroidal thickness and blood flow. Acta Ophthalmol. 2021 Nov;99(7):730-738. doi: 10.1111/aos.14773. Epub 2021 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: retinal blood flow; myopia; artificial lighting; accommodative micro-fluctuation
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: YFZXLDX20220801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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