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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594719
• Other study ID #: YFZXLDX20220801
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: October 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Xiangui He, PhD
• Phone: 021-62717733
• Email: xianhezi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Shorter-wavelength dominant light
Shorter-wavelength dominant light
• Light similar to the solar spectrum proportion
Light similar to the solar spectrum proportion with no specific wavelength dominant
• Longer-wavelength dominant light
Longer-wavelength dominant light

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention and Treatment Center	Shanghai	Shanghai
China	Xiangui He	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

References & Publications (6)

??, ???, ???, et al. ?????LED??????????????????????????. zgxxws. 2022;43(3):338-340. doi:10.16835/j.cnki.1000-9817.2022.03.005

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

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. Review. — View Citation

Mirhajianmoghadam H, Piña 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. — View Citation

Muralidharan AR, Lança 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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