NCT05594732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

June 8, 2023

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

October 1, 2022

Last Update Submit

June 7, 2023

Conditions

Keywords

myopiaretinal blood flowaccommodative micro-fluctuationoutdoor light exposure

Outcome Measures

Primary Outcomes (1)

  • 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.

    Exposing to sunlight for 15 minutes

Secondary Outcomes (1)

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

    Retinal blood flow density after relaxing for 5 and 15 minutes

Study Arms (2)

Weak outdoor light

EXPERIMENTAL

4000Lux natural light exposure

Behavioral: Weak outdoor light

Strong outdoor light

EXPERIMENTAL

10000Lux natural light exposure

Behavioral: Strong outdoor light

Interventions

Stay and stare far on the balcony or under the tree

Weak outdoor light

Stay and stare far in the sunlight

Strong outdoor light

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 200041, China

Location

Related Publications (5)

  • 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.

    PMID: 34473223BACKGROUND
  • 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.

    PMID: 31018118BACKGROUND
  • 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.

    PMID: 28251836BACKGROUND
  • 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.

    PMID: 33550704BACKGROUND
  • 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.

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Xiangui He

    Shanghai Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants were randomly divided into two groups without knowing the exposing mode.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The participants were randomly divided into the following two groups: 1. 4000Lux natural light exposure; 2. 10000Lux natural light exposure.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2022

First Posted

October 26, 2022

Study Start

September 6, 2022

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

June 8, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations