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

NCT ID: NCT05594719

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-06
• Study Completion Date: 2022-10-30

Brief 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.

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Light group 1

Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant;

Group Type: EXPERIMENTAL

Shorter-wavelength dominant light

Intervention Type: DEVICE

Shorter-wavelength dominant light

Light group 2

Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight

Group Type: PLACEBO_COMPARATOR

Light similar to the solar spectrum proportion

Intervention Type: DEVICE

Light similar to the solar spectrum proportion with no specific wavelength dominant

Light group 3

Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.

Group Type: EXPERIMENTAL

Shorter-wavelength dominant light

Intervention Type: DEVICE

Shorter-wavelength dominant light

Longer-wavelength dominant light

Intervention Type: DEVICE

Longer-wavelength dominant light

Interventions

Shorter-wavelength dominant light

Shorter-wavelength dominant light

Intervention Type: DEVICE

Light similar to the solar spectrum proportion

Light similar to the solar spectrum proportion with no specific wavelength dominant

Intervention Type: DEVICE

Longer-wavelength dominant light

Longer-wavelength dominant light

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangui He, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Eye Hospital

Locations

Xiangui He

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangui He, PhD

Role: CONTACT

xianhezi@163.com

021-62717733

Facility Contacts

Xiangui He, MD

Role: primary

xianhezi@163.com

+8615000755422

Xiangui He

Role: primary

021-62717733

References

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.

Reference Type: BACKGROUND

PMID: 34473223 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34988370 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31018118 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 33550704 (View on PubMed)

Other Identifiers

YFZXLDX20220801

Identifier Type: -

Identifier Source: org_study_id