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Not yet recruitingNCT06501131Updated Jul 15, 2024

A Self-controlled Study of the Effect of Partial Spectral Absence of Visible Light on the Pupil

An interventional study of full-spectrum light exposure and specific spectrum absence light exposure in Full Spectrum, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting. Open to participants aged 7 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
7 Years to 45 Years
Sex
All
01

Study summary

Previous studies have shown that the spectrum of light influences myopia. LED lights with a partially absent light spectrum increase the risk of myopia progression compared to LEDs with a full spectrum, potentially mediated by the excitability of the parasympathetic nervous system. This study intends to compare pupil size and area, as well as parameters regulated by the autonomic nervous system (such as skin bioelectrical activity and heart rate), between LEDs with a full visible spectrum and LEDs with a partially absent spectrum around 470nm and 730nm. We aim to elucidate the physiological mechanism underlying the effect of light spectrum on pupil changes and myopia.

02

Conditions studied

  • Full Spectrum

Keywords

  • myopia,spectrum,vegetative nerve,pupil
03

In context

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

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

04

Who can participate

Ages eligible
7 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    1. Age 7-45 years 2. Able to wear multi-channel physiological measurement devices and cooperate with experimental procedures.

      1. Binocular? spherical power between -0.50 to -5.00 diopters, and cylinder power no more than -1.50 diopters.
      1. Voluntarily participate in this study with informed consent form signed.

Exclusion criteria

Exclusion Criteria:

    1. History of diseases affecting autonomic nervous system function, such as depression and anxiety.

      1. History of eye diseases such as strabismus, amblyopia, keratitis, and glaucoma, which are unsuitable for eye movement test.
      1. History of major systemic diseases or surgeries such as cranial surgery, myocardial infarction, or stroke.
      1. Systemic medication history that may affect autonomic nervous system function, including but not limited to antidepressants, antihistamines, anticholinergics, antipsychotics, and sedative-hypnotic drugs like diazepam or lorazepam.
      1. Use of eyedrops such as mydriatics or miotics that will affect pupil size. 6. Having difficulty in understanding and cooperating with the trial, such as those with disabilities, communication barriers, or those unable to undertake examinations.
      1. Other contradictions that the physician may consider inappropriate for enrolment.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    full spectrum light group

    Subjects were asked to stay in a resting state for 5 minutes in a dark room, then turn on the full-spectrum light and adapt to the light environment for 5 minutes, and then take measurements for 5 minutes. After wash-out in the dark room for 5 minutes, change the light to ordinary LED lamp and repeat the above test steps for measurement.

    Other: full-spectrum light exposure

  • Experimental
    ordinary LED light group

    Subjects were asked to stay in a resting state for 5 minutes in a dark room, then turn on the ordinary LED lamp and adapt to the light environment for 5 minutes, and then take measurements for 5 minutes. After wash-out in the dark room for 5 minutes, change the light to full-spectrum light and repeat the above test steps for measurement.

    Other: specific spectrum absence light exposure

Interventions

  • Otherfull-spectrum light exposure

    Subjects will stay in a room with full spectrum light for 5 minutes. After 5 minutes wash-out period, altenate to the other arm.

  • Otherspecific spectrum absence light exposure

    Subjects will stay in a room with ordinary LED light for 5 minutes. After 5 minutes wash-out period, altenate to the other arm.

06

What researchers measure

Primary outcomes

  1. pupil size

    The pupil diameter is measured in real-time using the Eyelink Portable Duo eye tracker.

    Time frame: 5 minutes

Secondary outcomes

  1. Skin conductance response

    Rapidly changing and short-duration skin surface potentials measured in real-time using the Biopac MP160 multi-channel physiological recorder.

    Time frame: 5 minutes

  2. Respiratory movement

    The amplitude of respiratory movements measured in real-time using the Biopac MP160 multi-channel physiological recorder.

    Time frame: 5 minutes

  3. Pulse pressure waveform

    The amplitude of respiratory movements measured in real-time using the Biopac MP160 multi-channel physiological recorder.

    Time frame: 5 minutes

  4. Spherical equivalent refraction

    Measured with autorefractor and defined as the sum of spherical power and half of the cylinder power.

    Time frame: 5 minutes

  5. Uncorrected visual acuity

    Visual acuity without refractive correction.

    Time frame: 5 minutes

  6. Axial length

    Uncorrected visual acuity: Visual acuity without refractive correction.

    Time frame: 5 minutes

  7. Corneal curvature

    Anterior corneal curvature measured by the Pentacam corneal topographer

    Time frame: 5 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06501131
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Sponsor
First posted
Jul 15, 2024
Start date
Jul 24, 2024 (estimated)
Primary completion
Aug 31, 2024 (estimated)
Completion
Sep 30, 2024 (estimated)
Last update
Jul 15, 2024

Study contacts

Zeng Yangfa, Master's
Contact
zengyangfa@qq.com
18922103998

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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