MyopiaNCT05594719
The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow
A study testing Shorter-wavelength dominant light, Light similar to the solar spectrum proportion and Longer-wavelength dominant light in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 2 sites in China.
Trial summary
In 2020, the overall myopia rate among children and adolescents was 52.7% in China. 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?
- Shorter-wavelength dominant light, Light similar to the solar spectrum proportion and Longer-wavelength dominant light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesChina
- 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
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Xiangui He
Shanghai, Shanghai Municipality, 200040
Xiangui He, MD, +8615000755422, xianhezi@163.com
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 200041
Xiangui He, 021-62717733
About this study
Official title: The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow in School Students: a Randomized Controlled Trial
In 2020, the overall myopia rate among children and adolescents was 52.7% in China. 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 in addition to exposure to light intensity, the occurrence and development of myopia is also related to the color temperature and wavelength band of light. The sun-like spectrum refers to the spectrum with continuous wavelength bands. Animal experiments suggest that sun-like artificial lighting can prevent myopia, but the relationship between sun-like artificial lighting with different color temperatures and myopia is unknown. Clinical trials suggest that artificial lighting with a sun-like spectrum can delay fundus blood flow decline. One hypothesis is that reduced choroidal blood flow leads to scleral hypoxia and promotes the development of myopia. This study aims at comparing the effects of sun-like spectrum artificial lighting with different dominant wavelengths on the human eye, and providing 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 was 52.7% in China. 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 in addition to exposure to light intensity, the occurrence and development of myopia is also related to the color temperature and wavelength band of light. Animal experiments showed that the bandwidth of light had a significant effect on the emmetropia of the eye, and white light can promote emmetropia more than monochromatic light; longer-wavelength light and shorter-wavelength light can promote and inhibit the development of myopia through hyperopia and myopic defocus, respectively. At present, the artificial lighting methods on the market are mainly light emitting diode (LED), whose light spectrum is discontinuous. With the advancement of related research and lighting technology, multiple LED emission peaks and "sun-like spectrum" desk lamps have gradually appeared. The sun-like spectrum refers to the spectrum with continuous wavelength bands. Animal experiments suggest that sun-like artificial lighting can prevent myopia, but the relationship between sun-like artificial lighting with different color temperatures and myopia is unknown. Clinical trials suggest that artificial lighting with a sun-like spectrum can delay fundus blood flow decline. Fundus blood flow is sensitive to myopia stimuli, and is a short-term effect indicator of the relationship between light environment and myopia. One hypothesis is that reduced choroidal blood flow leads to scleral hypoxia and promotes the development of myopia. Therefore, in this study fundus blood flow was selected as the main research indicator, aiming to compare the effects of sun-like spectrum artificial lighting with different dominant wavelengths on the human eye, and provide clues for the prevention and control of myopia.
- Conditions
- Myopia
- Being tested
- Shorter-wavelength dominant light, Light similar to the solar spectrum proportion, Longer-wavelength dominant light
- Keywords
- myopia, retinal blood flow, accommodative micro-fluctuation, artificial lighting
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shorter-wavelength dominant lightDevice
Shorter-wavelength dominant light
Light similar to the solar spectrum proportionDevice
Light similar to the solar spectrum proportion with no specific wavelength dominant
Longer-wavelength dominant lightDevice
Longer-wavelength dominant light
| Study group | Role | What they receive |
|---|---|---|
| Light group 1 | Experimental | Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant; Receives: Device: Shorter-wavelength dominant light |
| Light group 2 | Placebo comparator | Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight Receives: Device: Light similar to the solar spectrum proportion |
| Light group 3 | Experimental | Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant. Receives: Device: Shorter-wavelength dominant light; Device: Longer-wavelength dominant light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal blood flow density after reading
Data werevcollected from Optovue AngioVue OCT (macular blood data collected), dominant eye examined
Measured: At the timepoint after reading for 1 hour
Secondary outcomes (1)
Accommodation ability after reading
Data were collected from AcomoREF2 (AMF mode, record distance and high-frequency component), for the dominant eye. And the Accommodative response value was documented for further analysis.
Measured: At the timepoint after reading for 1 hour
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 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 three groups: 1. Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant; 2. Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight; 3. Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangui He, PhD, Principal investigator, Shanghai Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594719
- Sponsor's protocol ID
- YFZXLDX20220801
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 26 Oct 2022
- 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 34473223Muralidharan AR, Lanca C, Biswas S, Barathi VA, Wan Yu Shermaine L, Seang-Mei S, Milea D, Najjar RP. Light and myopia: from epidemiological studies to neurobiological mechanisms. Ther Adv Ophthalmol. 2021 Dec 19;13:25158414211059246. doi: 10.1177/25158414211059246. eCollection 2021 Jan-Dec.
PubMed 34988370Rucker 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 31018118Baeza Moyano D, González-Lezcano RA. Pandemic of Childhood Myopia. Could New Indoor LED Lighting Be Part of the Solution? Energies. 2021;14(13):3827. doi:10.3390/en14133827
陈军, 陈友三, 王菁菁, et al. 类太阳光谱LED照明对儿童青少年视网膜血流灌注影响的随机对照临床试验. zgxxws. 2022;43(3):338-340. doi:10.16835/j.cnki.1000-9817.2022.03.005
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.
PubMed 33550704
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow in School Students: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05594719
- Acronym / sponsor ID
- YFZXLDX20220801
- Conditions
- Myopia
- Keywords
- myopia, retinal blood flow, accommodative micro-fluctuation, artificial lighting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- 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 was 52.7% in China. 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 in addition to exposure to light intensity, the occurrence and development of myopia is also related to the color temperature and wavelength band of light. The sun-like spectrum refers to the spectrum with continuous wavelength bands. Animal experiments suggest that sun-like artificial lighting can prevent myopia, but the relationship between sun-like artificial lighting with different color temperatures and myopia is unknown. Clinical trials suggest that artificial lighting with a sun-like spectrum can delay fundus blood flow decline. One hypothesis is that reduced choroidal blood flow leads to scleral hypoxia and promotes the development of myopia. This study aims at comparing the effects of sun-like spectrum artificial lighting with different dominant wavelengths on the human eye, and providing 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 was 52.7% in China. 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 in addition to exposure to light intensity, the occurrence and development of myopia is also related to the color temperature and wavelength band of light. Animal experiments showed that the bandwidth of light had a significant effect on the emmetropia of the eye, and white light can promote emmetropia more than monochromatic light; longer-wavelength light and shorter-wavelength light can promote and inhibit the development of myopia through hyperopia and myopic defocus, respectively. At present, the artificial lighting methods on the market are mainly light emitting diode (LED), whose light spectrum is discontinuous. With the advancement of related research and lighting technology, multiple LED emission peaks and "sun-like spectrum" desk lamps have gradually appeared. The sun-like spectrum refers to the spectrum with continuous wavelength bands. Animal experiments suggest that sun-like artificial lighting can prevent myopia, but the relationship between sun-like artificial lighting with different color temperatures and myopia is unknown. Clinical trials suggest that artificial lighting with a sun-like spectrum can delay fundus blood flow decline. Fundus blood flow is sensitive to myopia stimuli, and is a short-term effect indicator of the relationship between light environment and myopia. One hypothesis is that reduced choroidal blood flow leads to scleral hypoxia and promotes the development of myopia. Therefore, in this study fundus blood flow was selected as the main research indicator, aiming to compare the effects of sun-like spectrum artificial lighting with different dominant wavelengths on the human eye, 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
- 3
- Model description
- The participants were randomly divided into the following three groups: 1. Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant; 2. Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight; 3. Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.
| Arm | Type | Receives |
|---|---|---|
| Light group 1 | Experimental | Device: Shorter-wavelength dominant lightSun-like spectrum, color temperature of 5000K, shorter-wavelength dominant; |
| Light group 2 | Placebo comparator | Device: Light similar to the solar spectrum proportionSun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight |
| Light group 3 | Experimental | Device: Shorter-wavelength dominant light, Device: Longer-wavelength dominant lightSun-like spectrum, color temperature of 5000K, longer-wavelength dominant. |
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 |
|---|---|---|
| Shorter-wavelength dominant lightShorter-wavelength dominant light | Device | Light group 1, Light group 3 |
| Light similar to the solar spectrum proportionLight similar to the solar spectrum proportion with no specific wavelength dominant | Device | Light group 2 |
| Longer-wavelength dominant lightLonger-wavelength dominant light | Device | Light group 3 |
Primary outcome
Retinal blood flow density after reading
Time frame: At the timepoint after reading for 1 hour
Data werevcollected from Optovue AngioVue OCT (macular blood data collected), dominant eye examined
1 secondary outcome
Accommodation ability after reading
Time frame: At the timepoint after reading for 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- 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 34988370Muralidharan AR, Lanca C, Biswas S, Barathi VA, Wan Yu Shermaine L, Seang-Mei S, Milea D, Najjar RP. Light and myopia: from epidemiological studies to neurobiological mechanisms. Ther Adv Ophthalmol. 2021 Dec 19;13:25158414211059246. doi: 10.1177/25158414211059246. eCollection 2021 Jan-Dec.
- 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.
- BackgroundBaeza Moyano D, González-Lezcano RA. Pandemic of Childhood Myopia. Could New Indoor LED Lighting Be Part of the Solution? Energies. 2021;14(13):3827. doi:10.3390/en14133827
- Background陈军, 陈友三, 王菁菁, et al. 类太阳光谱LED照明对儿童青少年视网膜血流灌注影响的随机对照临床试验. zgxxws. 2022;43(3):338-340. doi:10.16835/j.cnki.1000-9817.2022.03.005
- 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.
- 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, PhD principal investigator
Shanghai Eye Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shorter-wavelength dominant light, Light similar to the solar spectrum proportion and Longer-wavelength dominant light in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 2 sites 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: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangui He, PhD (021-62717733, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal blood flow density after reading (time frame: At the timepoint after reading for 1 hour). 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 NCT05594719, which also lists 6 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 26 Oct 2022; AzTrials last refreshed its copy on 3 Nov 2026.