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

NCT ID: NCT06501131

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

full-spectrum light exposure

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

specific spectrum absence light exposure

Intervention Type: 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.

Interventions

full-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.

Intervention Type: OTHER

specific 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

3. Binocular? spherical power between -0.50 to -5.00 diopters, and cylinder power no more than -1.50 diopters.

4. 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.

2. History of eye diseases such as strabismus, amblyopia, keratitis, and glaucoma, which are unsuitable for eye movement test.

3. History of major systemic diseases or surgeries such as cranial surgery, myocardial infarction, or stroke.

4. 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.

5. 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.

7. Other contradictions that the physician may consider inappropriate for enrolment.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zeng Yangfa, Master's

Role: CONTACT

zengyangfa@qq.com

18922103998

Other Identifiers

2024KYPJ062

Identifier Type: -

Identifier Source: org_study_id