PupilNCT02636140
Color and Pupil Function
A study testing Light in people with Pupil, run by VA Palo Alto Health Care System.
Trial summary
This study will examine the effects of different colors of light on pupil function and alertness. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pupil
- What is being tested?
- Light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2016
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35
- Good health
Who cannot join
- Sleep disorder
- Extreme chronotype
- Smoker
- Abnormal color vision
- Ocular pathology (other than mild or moderate refractive error)
- Visual field defects
- Alcohol abuse
- Use of illegal drugs
About this study
Official title: Effect of Light Spectrum on Pupil Function
This study will examine the effects of different colors of light on pupil function and alertness.
- Conditions
- Pupil
- Being tested
- Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightOther
A brief, 1 minute exposure to light of varying color and intensity. The combination of color and intensity will be the same in all participants, but the order in which they are received is randomized.
| Study group | Role | What they receive |
|---|---|---|
| Light | Experimental | Randomized amount and color of light Receives: Other: Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pupil size
Change in pupil size from baseline during and following brief light exposure
Measured: Baseline and 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PupilStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636140
- Sponsor's protocol ID
- IRB-36326
- Status last verified
- Nov 2016
- First submitted
- 17 Dec 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light Spectrum on Pupil Function
- ClinicalTrials.gov ID
- NCT02636140
- Acronym / sponsor ID
- IRB-36326
- Conditions
- Pupil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 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.
This study will examine the effects of different colors of light on pupil function and alertness.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light | Experimental | Other: LightRandomized amount and color of light |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-35
- Good health
Key exclusion criteria (8 listed)
- Sleep disorder
- Extreme chronotype
- Smoker
- Abnormal color vision
- Ocular pathology (other than mild or moderate refractive error)
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 |
|---|---|---|
| LightA brief, 1 minute exposure to light of varying color and intensity. The combination of color and intensity will be the same in all participants, but the order in which they are received is randomized. | Other | Light |
Primary outcome
Change in pupil size
Time frame: Baseline and 10 minutes
Change in pupil size from baseline during and following brief light exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Light in people with Pupil, run by VA Palo Alto Health Care System.
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 8 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: finished, as of the sponsor's last update on 2 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in pupil size (time frame: Baseline and 10 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 2 Nov 2016.