Light Flashing EffectsNCT02629471
Study of the Effects of Light Flashes on the Visual System
A study testing response time due to light flash pulses in people with Light Flashing Effects, run by LightGuard at 1 site in Israel.
Trial summary
Background The goal of this study is to examine the human visual and cognitive performance under the effect of bright light pulses. Exposure to visual stimulation of such pulsation may interfere with cognitive function and at certain situations this may be noticeable and may interfere with our judgment and abilities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Light Flashing Effects
- What is being tested?
- response time due to light flash pulses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Feb 2017to Mar 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically and visually Healthy (per history)
- Signed Informed Consent
Who cannot join
- Pregnant women
- Unwilling to sign informed consent
- Current and past history of migraine
- Current and post history of epilepsy or seizures
- Any known ocular disease in one or two eyes
Trial locations and contacts
1 site in 1 country.
About this study
Background The goal of this study is to examine the human visual and cognitive performance under the effect of bright light pulses. Exposure to visual stimulation of such pulsation may interfere with cognitive function and at certain situations this may be noticeable and may interfere with our judgment and abilities. In some of them visual or cognitive impairment from exposure to bright light flashes may result in catastrophic outcome due to the high-risk situation e.g. road accidents. Ocular exposure to a bright light can result in profound momentary transitional loss of vision. The light sources employed for visual stimulation in this study will be restricted to the range consistent with "reversible effects" (e.g. glare and flash insensitivity or "flash blindness").
The impact of an exposure to bright light depends not only on the exposure level and frequency, but also on the exposed individual's activity, psychological state, adaptation level and visual task. Glare is primarily caused by the scattering of light within the eye due to the imperfect transparency of the optical components of the eye and to a lesser extent by diffuse light passing through the scleral wall or the iris. The scattered light overlays the retinal image, thus reducing visual contrast. Excessive glare may impair visual function and lead to temporary disability.
The above mentioned effects of exposure to light and pulsating light stimulus on the visual system and cognition were studied in detail by a number of groups. These studies indicate that the visual and cognition effects of pulsating light are a function of the following parameters: pulse duration, light intensity and pulse frequency.
Read the detailed description
Study Purpose and Rationale The purpose of this study is to evaluate the cognitive effects of exposure to flashing light stimuli by measuring the response time and level of performance of healthy human subjects during exposure to light pulsations.
Study Design and methods:
- Overall study design An open prospective study comprising of cognitive tests performed during and following exposure to bright flashing light stimuli. Pre and post -cognitive test (within 1 month after the test) ophthalmological tests will be conducted.
- Study Participants A total of 60 subjects will be recruited for this study over a span of 3 months.
The subjects will volunteer to participate in the study. Flash Tests The subject will be positioned at a selected distance from a flashing unit and a screen on which different scenarios will be projected.
The subject will be exposed to the flashing light generated by the study device with various parameters (Pulse width, Repetition Rate (RR), Intensity). Static and dynamic targets, will appear on the screen at random locations and the subject will be instructed to response by aiming a narrow light beam at the targets on the screen. A CCD camera will capture the screen scenarios.
- Conditions
- Light Flashing Effects
- Being tested
- response time due to light flash pulses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
response time due to light flash pulsesBehavioural
light flash pulses effect on response time to random targets appearance
| Study group | Role | What they receive |
|---|---|---|
| response time due to light flashs pulses | Experimental | light flashing effects on response time to random target appearance Receives: Behavioral: response time due to light flash pulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual cognition
response time to targets after flashes
Measured: instantaneous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study start6 Feb 2017
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: Analyzing data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light Flashing EffectsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LightGuard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiri Soudry, DR, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629471
- Sponsor's protocol ID
- LG01
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2015
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Light Flashes on the Visual System
- ClinicalTrials.gov ID
- NCT02629471
- Acronym / sponsor ID
- LG01
- Conditions
- Light Flashing Effects
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Analyzing data
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LightGuardIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 14 Dec 2015 (estimated)
- 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.
Background The goal of this study is to examine the human visual and cognitive performance under the effect of bright light pulses. Exposure to visual stimulation of such pulsation may interfere with cognitive function and at certain situations this may be noticeable and may interfere with our judgment and abilities. In some of them visual or cognitive impairment from exposure to bright light flashes may result in catastrophic outcome due to the high-risk situation e.g. road accidents. Ocular exposure to a bright light can result in profound momentary transitional loss of vision. The light sources employed for visual stimulation in this study will be restricted to the range consistent with "reversible effects" (e.g. glare and flash insensitivity or "flash blindness").
The impact of an exposure to bright light depends not only on the exposure level and frequency, but also on the exposed individual's activity, psychological state, adaptation level and visual task. Glare is primarily caused by the scattering of light within the eye due to the imperfect transparency of the optical components of the eye and to a lesser extent by diffuse light passing through the scleral wall or the iris. The scattered light overlays the retinal image, thus reducing visual contrast. Excessive glare may impair visual function and lead to temporary disability.
The above mentioned effects of exposure to light and pulsating light stimulus on the visual system and cognition were studied in detail by a number of groups. These studies indicate that the visual and cognition effects of pulsating light are a function of the following parameters: pulse duration, light intensity and pulse frequency.
Detailed description
Study Purpose and Rationale The purpose of this study is to evaluate the cognitive effects of exposure to flashing light stimuli by measuring the response time and level of performance of healthy human subjects during exposure to light pulsations.
Study Design and methods:
- Overall study design An open prospective study comprising of cognitive tests performed during and following exposure to bright flashing light stimuli. Pre and post -cognitive test (within 1 month after the test) ophthalmological tests will be conducted.
- Study Participants A total of 60 subjects will be recruited for this study over a span of 3 months.
The subjects will volunteer to participate in the study. Flash Tests The subject will be positioned at a selected distance from a flashing unit and a screen on which different scenarios will be projected.
The subject will be exposed to the flashing light generated by the study device with various parameters (Pulse width, Repetition Rate (RR), Intensity). Static and dynamic targets, will appear on the screen at random locations and the subject will be instructed to response by aiming a narrow light beam at the targets on the screen. A CCD camera will capture the screen scenarios.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| response time due to light flashs pulses | Experimental | Behavioral: response time due to light flash pulseslight flashing effects on response time to random target appearance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Systemically and visually Healthy (per history)
- Signed Informed Consent
Key exclusion criteria (5 listed)
- Pregnant women
- Unwilling to sign informed consent
- Current and past history of migraine
- Current and post history of epilepsy or seizures
- Any known ocular disease in one or two eyes
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 |
|---|---|---|
| response time due to light flash pulseslight flash pulses effect on response time to random targets appearance | Behavioural | response time due to light flashs pulses |
Primary outcome
visual cognition
Time frame: instantaneous
response time to targets after flashes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Shiri Soudry, DR principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing response time due to light flash pulses in people with Light Flashing Effects, run by LightGuard at 1 site in Israel.
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 2 inclusion and 5 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: paused, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual cognition (time frame: instantaneous). 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 24 Feb 2020.