search
Back to results

The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Weak outdoor light
Strong outdoor light
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring myopia, retinal blood flow, accommodative micro-fluctuation, outdoor light exposure

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

  • Shanghai Eye Disease Prevention and Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Weak outdoor light

Strong outdoor light

Arm Description

4000Lux natural light exposure

10000Lux natural light exposure

Outcomes

Primary Outcome Measures

Retinal blood flow density after relaxing 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.

Secondary Outcome Measures

Retinal blood flow density changes between relaxing for 5 and 15 minutes
The difference in retinal blood flow density was calculated between 5 and 15 minutes.

Full Information

First Posted
October 1, 2022
Last Updated
June 7, 2023
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05594732
Brief Title
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
Official Title
The Effects of Different Outdoor Light Exposure Modes 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
Completed
Study Start Date
September 6, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)

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 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.
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.

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, outdoor light exposure

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 two groups: 4000Lux natural light exposure; 10000Lux natural light exposure.
Masking
Participant
Masking Description
The participants were randomly divided into two groups without knowing the exposing mode.
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weak outdoor light
Arm Type
Experimental
Arm Description
4000Lux natural light exposure
Arm Title
Strong outdoor light
Arm Type
Experimental
Arm Description
10000Lux natural light exposure
Intervention Type
Behavioral
Intervention Name(s)
Weak outdoor light
Intervention Description
Stay and stare far on the balcony or under the tree
Intervention Type
Behavioral
Intervention Name(s)
Strong outdoor light
Intervention Description
Stay and stare far in the sunlight
Primary Outcome Measure Information:
Title
Retinal blood flow density after relaxing for 15 minutes
Description
Data collected from Optovue AngioVue OCT (macular blood data collected) for the dominant eye. The duration of relaxing was recorded by a timer.
Time Frame
Exposing to sunlight for 15 minutes
Secondary Outcome Measure Information:
Title
Retinal blood flow density changes between relaxing for 5 and 15 minutes
Description
The difference in retinal blood flow density was calculated between 5 and 15 minutes.
Time Frame
Retinal blood flow density after relaxing for 5 and 15 minutes

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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangui He
Organizational Affiliation
Shanghai Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Eye Disease Prevention and Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200041
Country
China

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
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
PubMed Identifier
28251836
Citation
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.
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

Learn more about this trial

The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow

We'll reach out to this number within 24 hrs