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Clinical Trials/NCT05594732
NCT05594732CompletedNot Applicable

The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow in School Students: a Randomized Controlled Trial

Shanghai Eye Disease Prevention and Treatment Center1 site in 1 country81 target enrollmentStarted: September 6, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
81
Locations
1
Primary Endpoint
Retinal blood flow density after relaxing for 15 minutes

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Masking Description

The participants were randomly divided into two groups without knowing the exposing mode.

Eligibility Criteria

Ages
7 Years to 15 Years (Child)
Sex
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.

Arms & Interventions

Strong outdoor light

Experimental

10000Lux natural light exposure

Intervention: Strong outdoor light (Behavioral)

Weak outdoor light

Experimental

4000Lux natural light exposure

Intervention: Weak outdoor light (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Retinal blood flow density changes between relaxing for 5 and 15 minutes(Retinal blood flow density after relaxing for 5 and 15 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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