Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06501131

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

7 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age 7-45 years 2. Able to wear multi-channel physiological measurement devices and cooperate with experimental procedures.
  • Binocular? spherical power between -0.50 to -5.00 diopters, and cylinder power no more than -1.50 diopters.
  • Voluntarily participate in this study with informed consent form signed.

Exclusion criteria

  • 1. History of diseases affecting autonomic nervous system function, such as depression and anxiety.
  • History of eye diseases such as strabismus, amblyopia, keratitis, and glaucoma, which are unsuitable for eye movement test.
  • History of major systemic diseases or surgeries such as cranial surgery, myocardial infarction, or stroke.
  • 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.
  • 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.
  • Other contradictions that the physician may consider inappropriate for enrolment.

Treatment and study plan

Full-spectrum light exposure

Other

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

specific spectrum absence light exposure

Other

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

Primary outcomes

  1. pupil size

    Time frame: 5 minutes

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

Secondary outcomes

  1. Skin conductance response

    Time frame: 5 minutes

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

  2. Respiratory movement

    Time frame: 5 minutes

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

  3. Pulse pressure waveform

    Time frame: 5 minutes

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

  4. Spherical equivalent refraction

    Time frame: 5 minutes

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

  5. Uncorrected visual acuity

    Time frame: 5 minutes

    Visual acuity without refractive correction.

  6. Axial length

    Time frame: 5 minutes

    Uncorrected visual acuity: Visual acuity without refractive correction.

  7. Corneal curvature

    Time frame: 5 minutes

    Anterior corneal curvature measured by the Pentacam corneal topographer

Study contacts

Contact information is provided by the study sponsor or research team.

Zeng Yangfa, Master's

CONTACT

[email protected]

18922103998

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

The Impact of Partial Visible Light Spectrum Absence on Pupil Response and Autonomic Nervous System Excitability: A Cross-Over Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.