- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05594732
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
June 7, 2023 updated by: Shanghai Eye Disease Prevention and Treatment Center
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow in School Students: a Randomized Controlled Trial
In 2020, the overall myopia rate among children and adolescents in my country was 52.7%.
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 the light wave bandwidth has a significant impact on the emmetropization of the eye, and white light can promote emmetropia more than monochromatic light.
It shows that outdoor exercise has a protective effect on the occurrence and development of myopia in children and adolescents, but the specific mechanism is still unclear.
Retinal blood flow is sensitive to myopic stimuli, and is a short-term indicator of the relationship between light environment and myopia.
This study selected retinal blood flow as the primary outcome, aiming to compare the effects of different outdoor light exposure modes on retinal blood flow after 1 hour of intense eye use, and provide clues for the prevention and control of myopia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 in my country was 52.7%.
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 the light wave bandwidth has a significant impact on the emmetropization of the eye, and white light can promote emmetropia more than monochromatic light.
It shows that outdoor exercise has a protective effect on the occurrence and development of myopia in children and adolescents, but the specific mechanism is still unclear.
Retinal blood flow is sensitive to myopic stimuli, and is a short-term indicator of the relationship between light environment and myopia.
Also, there is a theory that reduced choroidal blood flow causes scleral hypoxia, which leads to the development of myopia.
Therefore, this study selected retinal blood flow as the primary outcome, aiming to compare the effects of different outdoor light exposure modes on retinal blood flow after 1 hour of intense eye use, and provide clues for the prevention and control of myopia.
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200041
- Shanghai Eye Disease Prevention and Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 11 years (Child)
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Weak outdoor light
4000Lux natural light exposure
|
Stay and stare far on the balcony or under the tree
|
|
Experimental: Strong outdoor light
10000Lux natural light exposure
|
Stay and stare far in the sunlight
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retinal blood flow density after relaxing for 15 minutes
Time Frame: Exposing to sunlight for 15 minutes
|
Data collected from Optovue AngioVue OCT (macular blood data collected) for the dominant eye.
The duration of relaxing was recorded by a timer.
|
Exposing to sunlight for 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retinal blood flow density changes between relaxing for 5 and 15 minutes
Time Frame: Retinal blood flow density after relaxing for 5 and 15 minutes
|
The difference in retinal blood flow density was calculated between 5 and 15 minutes.
|
Retinal blood flow density after relaxing for 5 and 15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiangui He, Shanghai Eye Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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.
- 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.
- 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.
- Xiong S, Sankaridurg P, Naduvilath T, Zang J, Zou H, Zhu J, Lv M, He X, Xu X. Time spent in outdoor activities in relation to myopia prevention and control: a meta-analysis and systematic review. Acta Ophthalmol. 2017 Sep;95(6):551-566. doi: 10.1111/aos.13403. Epub 2017 Mar 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2022
Primary Completion (Actual)
October 30, 2022
Study Completion (Actual)
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)
June 8, 2023
Last Update Submitted That Met QC Criteria
June 7, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YFZXLDX20220802
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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