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

Sponsor
Shanghai Eye Disease Prevention and Treatment Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05594732
Collaborator
(none)
75
1
2
1.8
42.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Weak outdoor light
  • Behavioral: Strong outdoor light
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The participants were randomly divided into the following two groups: 4000Lux natural light exposure; 10000Lux natural light exposure.The participants were randomly divided into the following two groups:4000Lux natural light exposure; 10000Lux natural light exposure.
Masking:
Single (Participant)
Masking Description:
The participants were randomly divided into two groups without knowing the exposing mode.
Primary Purpose:
Prevention
Official Title:
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow in School Students: a Randomized Controlled Trial
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Weak outdoor light

4000Lux natural light exposure

Behavioral: Weak outdoor light
Stay and stare far on the balcony or under the tree

Experimental: Strong outdoor light

10000Lux natural light exposure

Behavioral: Strong outdoor light
Stay and stare far in the sunlight

Outcome Measures

Primary Outcome Measures

  1. Retinal blood flow density after relaxing for 15 minutes [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.

Secondary Outcome Measures

  1. Retinal blood flow density changes between relaxing for 5 and 15 minutes [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Eye Disease Prevention and Treatment Center Shanghai Shanghai China 200041

Sponsors and Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

Investigators

  • Principal Investigator: Xiangui He, Shanghai Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier:
NCT05594732
Other Study ID Numbers:
  • YFZXLDX20220802
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Eye Disease Prevention and Treatment Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022