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

NCT ID: NCT05594732

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2022-10-30

Brief Summary

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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

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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.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants were randomly divided into the following two groups:

1. 4000Lux natural light exposure;
2. 10000Lux natural light exposure.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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Weak outdoor light

4000Lux natural light exposure

Group Type EXPERIMENTAL

Weak outdoor light

Intervention Type BEHAVIORAL

Stay and stare far on the balcony or under the tree

Strong outdoor light

10000Lux natural light exposure

Group Type EXPERIMENTAL

Strong outdoor light

Intervention Type BEHAVIORAL

Stay and stare far in the sunlight

Interventions

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Weak outdoor light

Stay and stare far on the balcony or under the tree

Intervention Type BEHAVIORAL

Strong outdoor light

Stay and stare far in the sunlight

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiangui He

Role: PRINCIPAL_INVESTIGATOR

Shanghai Eye Hospital

Locations

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Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 34473223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31018118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28251836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33550704 (View on PubMed)

Zhao L, Zhang B, Wang J, Yang J, Du L, Wang T, Xu X, He X, Chen J. Short-term effects of sunlight exposure on fundus blood flow perfusion in children: a randomised controlled trial. Br J Ophthalmol. 2024 Dec 17;109(1):139-145. doi: 10.1136/bjo-2024-325715.

Reference Type DERIVED
PMID: 38981665 (View on PubMed)

Other Identifiers

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YFZXLDX20220802

Identifier Type: -

Identifier Source: org_study_id

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