MyopiaNCT05594732
The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow
A study testing Weak outdoor light and Strong outdoor light in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Myopia
- What is being tested?
- Weak outdoor light and Strong outdoor light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200041
About this study
Official title: 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.
Read the 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.
- Conditions
- Myopia
- Being tested
- Weak outdoor light, Strong outdoor light
- Keywords
- myopia, retinal blood flow, accommodative micro-fluctuation, outdoor light exposure
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weak outdoor lightBehavioural
Stay and stare far on the balcony or under the tree
Strong outdoor lightBehavioural
Stay and stare far in the sunlight
| Study group | Role | What they receive |
|---|---|---|
| Weak outdoor light | Experimental | 4000Lux natural light exposure Receives: Behavioral: Weak outdoor light |
| Strong outdoor light | Experimental | 10000Lux natural light exposure Receives: Behavioral: Strong outdoor light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Exposing to sunlight for 15 minutes
Secondary outcomes (1)
Retinal blood flow density changes between relaxing for 5 and 15 minutes
The difference in retinal blood flow density was calculated between 5 and 15 minutes.
Measured: Retinal blood flow density after relaxing for 5 and 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start6 Sep 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were randomly divided into the following two groups: 1. 4000Lux natural light exposure; 2. 10000Lux natural light exposure.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangui He, Principal investigator, Shanghai Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594732
- Sponsor's protocol ID
- YFZXLDX20220802
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34473223Rucker 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.
PubMed 31018118Xiong 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.
PubMed 28251836Liu 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.
PubMed 33550704Zhao 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.
PubMed 38981665
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Different Outdoor Light Exposure Modes on Retinal Blood Flow in School Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05594732
- Acronym / sponsor ID
- YFZXLDX20220802
- Conditions
- Myopia
- Keywords
- myopia, retinal blood flow, accommodative micro-fluctuation, outdoor light exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The participants were randomly divided into the following two groups: 1. 4000Lux natural light exposure; 2. 10000Lux natural light exposure.
| Arm | Type | Receives |
|---|---|---|
| Weak outdoor light | Experimental | Behavioral: Weak outdoor light4000Lux natural light exposure |
| Strong outdoor light | Experimental | Behavioral: Strong outdoor light10000Lux natural light exposure |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weak outdoor lightStay and stare far on the balcony or under the tree | Behavioural | Weak outdoor light |
| Strong outdoor lightStay and stare far in the sunlight | Behavioural | Strong outdoor light |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Background: PubMed 34473223Mirhajianmoghadam 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.
- Background: PubMed 31018118Rucker 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.
- Background: PubMed 28251836Xiong 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.
- Background: PubMed 33550704Liu 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.
- Derived from this study: PubMed 38981665Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangui He principal investigator
Shanghai Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weak outdoor light and Strong outdoor light in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal blood flow density after relaxing for 15 minutes (time frame: Exposing to sunlight for 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05594732, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.