The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
1 other identifier
interventional
75
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2022
CompletedFirst Submitted
Initial submission to the registry
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedOctober 26, 2022
October 1, 2022
2 months
October 1, 2022
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Accommodation ability after reading
At the timepoint after reading for 1 hour
Study Arms (3)
Light group 1
EXPERIMENTALSun-like spectrum, color temperature of 5000K, shorter-wavelength dominant;
Light group 2
PLACEBO COMPARATORSun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight
Light group 3
EXPERIMENTALSun-like spectrum, color temperature of 5000K, longer-wavelength dominant.
Interventions
Light similar to the solar spectrum proportion with no specific wavelength dominant
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Xiangui He
Shanghai, Shanghai Municipality, 200040, China
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200041, China
Related Publications (6)
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.
PMID: 34473223BACKGROUNDMuralidharan 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.
PMID: 34988370BACKGROUNDRucker 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.
PMID: 31018118BACKGROUNDBaeza 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
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
BACKGROUNDLiu 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.
PMID: 33550704BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangui He, PhD
Shanghai Eye Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participants were randomly divided into three groups without knowing the type of light
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2022
First Posted
October 26, 2022
Study Start
September 6, 2022
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
October 26, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share