Full SpectrumNCT06501131
A Self-controlled Study of the Effect of Partial Spectral Absence of Visible Light on the Pupil
A study testing full-spectrum light exposure and specific spectrum absence light exposure in people with Full Spectrum, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Full Spectrum
- What is being tested?
- full-spectrum light exposure and specific spectrum absence light exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Partial Visible Light Spectrum Absence on Pupil Response and Autonomic Nervous System Excitability: A Cross-Over Randomized Controlled Trial
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
- Being tested
- full-spectrum light exposure, specific spectrum absence light exposure
- Keywords
- myopia,spectrum,vegetative nerve,pupil
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full-spectrum light exposureOther
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 exposureOther
Subjects will stay in a room with ordinary LED light for 5 minutes. After 5 minutes wash-out period, altenate to the other arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: specific spectrum absence light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupil size
The pupil diameter is measured in real-time using the Eyelink Portable Duo eye tracker.
Measured: 5 minutes
Secondary outcomes (7)
Skin conductance response
Rapidly changing and short-duration skin surface potentials measured in real-time using the Biopac MP160 multi-channel physiological recorder.
Measured: 5 minutes
Respiratory movement
The amplitude of respiratory movements measured in real-time using the Biopac MP160 multi-channel physiological recorder.
Measured: 5 minutes
Pulse pressure waveform
The amplitude of respiratory movements measured in real-time using the Biopac MP160 multi-channel physiological recorder.
Measured: 5 minutes
Spherical equivalent refraction
Measured with autorefractor and defined as the sum of spherical power and half of the cylinder power.
Measured: 5 minutes
Uncorrected visual acuity
Visual acuity without refractive correction.
Measured: 5 minutes
Axial length
Uncorrected visual acuity: Visual acuity without refractive correction.
Measured: 5 minutes
Corneal curvature
Anterior corneal curvature measured by the Pentacam corneal topographer
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start24 Jul 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full SpectrumStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501131
- Sponsor's protocol ID
- 2024KYPJ062
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Partial Visible Light Spectrum Absence on Pupil Response and Autonomic Nervous System Excitability: A Cross-Over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06501131
- Acronym / sponsor ID
- 2024KYPJ062
- Conditions
- Full Spectrum
- Keywords
- myopia,spectrum,vegetative nerve,pupil
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| full spectrum light group | Experimental | Other: full-spectrum light exposureSubjects 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. |
| ordinary LED light group | Experimental | Other: specific spectrum absence light exposureSubjects 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. |
Who may qualify
- Ages
- 7 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full-spectrum light exposureSubjects will stay in a room with full spectrum light for 5 minutes. After 5 minutes wash-out period, altenate to the other arm. | Other | full spectrum light group |
| specific spectrum absence light exposureSubjects will stay in a room with ordinary LED light for 5 minutes. After 5 minutes wash-out period, altenate to the other arm. | Other | ordinary LED light group |
Primary outcome
pupil size
Time frame: 5 minutes
The pupil diameter is measured in real-time using the Eyelink Portable Duo eye tracker.
7 secondary outcomes
Skin conductance response
Time frame: 5 minutes
Respiratory movement
Time frame: 5 minutes
Pulse pressure waveform
Time frame: 5 minutes
Spherical equivalent refraction
Time frame: 5 minutes
Uncorrected visual acuity
Time frame: 5 minutes
Axial length
Time frame: 5 minutes
Corneal curvature
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing full-spectrum light exposure and specific spectrum absence light exposure in people with Full Spectrum, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeng Yangfa, Master's (18922103998, zengyangfa@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pupil size (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.