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Status unknownNCT05594719Updated Oct 26, 2022

The Effect of Sun-like Spectrum With Different Spectrum Composition on Retinal Blood Flow

An interventional study of Shorter-wavelength dominant light and Light similar to the solar spectrum proportion in Myopia, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Status unknown at 2 sites in China. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
7 Years to 15 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Myopia

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Keywords

  • myopia
  • retinal blood flow
  • accommodative micro-fluctuation
  • artificial lighting
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In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 75 is close to the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 15 Years
Sexes eligible
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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Light group 1

    Sun-like spectrum, color temperature of 5000K, shorter-wavelength dominant;

    Device: Shorter-wavelength dominant light

  • Placebo comparator
    Light group 2

    Sun-like spectrum, color temperature of 5000K, wavelength proportion similar to the sunlight

    Device: Light similar to the solar spectrum proportion

  • Experimental
    Light group 3

    Sun-like spectrum, color temperature of 5000K, longer-wavelength dominant.

    Device: Shorter-wavelength dominant light · Device: Longer-wavelength dominant light

Interventions

  • DeviceShorter-wavelength dominant light

    Shorter-wavelength dominant light

  • DeviceLight similar to the solar spectrum proportion

    Light similar to the solar spectrum proportion with no specific wavelength dominant

  • DeviceLonger-wavelength dominant light

    Longer-wavelength dominant light

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What researchers measure

Primary outcomes

  1. Retinal blood flow density after reading

    Data werevcollected from Optovue AngioVue OCT (macular blood data collected), dominant eye examined

    Time frame: 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.

    Time frame: At the timepoint after reading for 1 hour

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Study locations

2 of 2 sites recruiting
  • Xiangui He
    Shanghai, Shanghai 200040, China
    Recruiting
  • Shanghai Eye Disease Prevention and Treatment Center
    Shanghai, Shanghai 200041, China
    • Xiangui He · Contact · 021-62717733
    Recruiting
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References and documents

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 34473223 ↗
  • Muralidharan 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 34988370 ↗
  • 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. PubMed 31018118 ↗
  • Baeza 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05594719
Lead sponsor
Shanghai Eye Disease Prevention and Treatment Center
Responsible party
Sponsor
First posted
Oct 26, 2022
Start date
Sep 6, 2022
Primary completion
Oct 30, 2022 (estimated)
Completion
Oct 30, 2022 (estimated)
Last update
Oct 26, 2022

Study contacts

Xiangui He, PhD
Contact
xianhezi@163.com
021-62717733
Xiangui He, PhD
principal investigator · Shanghai Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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