The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
Primary Purpose
Myopia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Shorter-wavelength dominant light
Light similar to the solar spectrum proportion
Longer-wavelength dominant light
Sponsored by
About this trial
This is an interventional prevention trial for Myopia focused on measuring myopia, retinal blood flow, accommodative micro-fluctuation, artificial lighting
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.
Sites / Locations
- Xiangui HeRecruiting
- Shanghai Eye Disease Prevention and Treatment CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
Light group 1
Light group 2
Light group 3
Arm Description
Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant;
Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight
Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.
Outcomes
Primary Outcome Measures
Retinal blood flow density after reading
Data werevcollected from Optovue AngioVue OCT (macular blood data collected), dominant eye examined
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05594719
First Posted
October 1, 2022
Last Updated
October 25, 2022
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
1. Study Identification
Unique Protocol Identification Number
NCT05594719
Brief Title
The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
Official Title
The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow in School Students: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
myopia, retinal blood flow, accommodative micro-fluctuation, artificial lighting
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants were randomly divided into the following three groups:
Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant;
Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight;
Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.
Masking
Participant
Masking Description
The participants were randomly divided into three groups without knowing the type of light
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Light group 1
Arm Type
Experimental
Arm Description
Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant;
Arm Title
Light group 2
Arm Type
Placebo Comparator
Arm Description
Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight
Arm Title
Light group 3
Arm Type
Experimental
Arm Description
Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.
Intervention Type
Device
Intervention Name(s)
Shorter-wavelength dominant light
Intervention Description
Shorter-wavelength dominant light
Intervention Type
Device
Intervention Name(s)
Light similar to the solar spectrum proportion
Intervention Description
Light similar to the solar spectrum proportion with no specific wavelength dominant
Intervention Type
Device
Intervention Name(s)
Longer-wavelength dominant light
Intervention Description
Longer-wavelength dominant light
Primary Outcome Measure Information:
Title
Retinal blood flow density after reading
Description
Data werevcollected from Optovue AngioVue OCT (macular blood data collected), dominant eye examined
Time Frame
At the timepoint after reading for 1 hour
Secondary Outcome Measure Information:
Title
Accommodation ability after reading
Description
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.
Time Frame
At the timepoint after reading for 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangui He, PhD
Phone
021-62717733
Email
xianhezi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangui He, PhD
Organizational Affiliation
Shanghai Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangui He
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangui He, MD
Phone
+8615000755422
Email
xianhezi@163.com
Facility Name
Shanghai Eye Disease Prevention and Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangui He
Phone
021-62717733
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34473223
Citation
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.
Results Reference
background
PubMed Identifier
34988370
Citation
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.
Results Reference
background
PubMed Identifier
31018118
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.
Results Reference
background
Citation
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
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
33550704
Citation
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.
Results Reference
background
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The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
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