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

NCT06501131 | Not Yet Recruiting

• 1 other identifier: 2024KYPJ062
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Full Spectrum

Keywords

myopia,spectrum,vegetative nerve,pupil

Outcome Measures

Primary Outcomes (1)

• pupil size

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

  5 minutes

Secondary Outcomes (7)

• Skin conductance response

  5 minutes

• Respiratory movement

  5 minutes

• Pulse pressure waveform

  5 minutes

• Spherical equivalent refraction

  5 minutes

• Uncorrected visual acuity

  5 minutes

Study Arms (2)

full spectrum light group

EXPERIMENTAL

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

ordinary LED light group

EXPERIMENTAL

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

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.

full spectrum light group

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.

ordinary LED light group

Eligibility Criteria

• Age: 7 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Zeng Yangfa, Master's

CONTACT

18922103998; zengyangfa@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: July 24, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07