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

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

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.

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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