Color Blindness, AcquiredNCT01927536
Evaluating Color Perception Under LED Red/Green and Green Dominant Light
An observational study of Color Blindness, Acquired, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators are testing a Light-emitting Diode (LED) flashlight from First-Light™ USA called the Tomahawk MC Tactical Light to determine the range of colors people are able to see with these flashlights at night. Read more about this study
- Who is it for?
- Ages 18 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Color Blindness, Acquired
- What is being tested?
- White LED Flashlight and Red/Green Green Dominant LED Flashlight
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2013to 10 Jan 2019
- Phase
- Observational
- 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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal color vision status
Who may be able to join
- normal vision
- 18-65 years
Who cannot join
- blindness
- colorblind
- pregnant women
- prisoners
- decisionally challenged
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Dept of Opthalmology
Aurora, Colorado, 80045
About this study
The investigators are testing a Light-emitting Diode (LED) flashlight from First-Light™ USA called the Tomahawk MC Tactical Light to determine the range of colors people are able to see with these flashlights at night. The flashlight has been designed to reduce visibility of the user and uses a combination of green and red LED lamps to achieve this. In this study investigators wish to determine how well a subject can differentiate colors at night in a quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which requires the user to put shades of red, green, blue and yellow into progressive color order which is scored according to the manufactures specifications.
- Conditions
- Color Blindness, Acquired
- Being tested
- White LED Flashlight, Red/Green Green Dominant LED Flashlight
- Medical subject headings
- Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White LED FlashlightDevice
Also called Tomahawk serial number TMC12420
white light setting
Red/Green Green Dominant LED FlashlightDevice
Also called Tomahawk serial number TMC12420, green dominant setting
Green LED light dominant setting
| Study group | Role | What they receive |
|---|---|---|
| Night Vision | White LED Flashlight, Red/Green Green Dominant LED Flashlight Receives: Device: White LED Flashlight; Device: Red/Green Green Dominant LED Flashlight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Normal Color vision
The Farnsworth Munsell 100 Hue Test is used to determine normal color vision and vision using the red green Tomahawk LED flashlight.
Measured: 1 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study start23 Apr 2013
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Color Blindness, AcquiredStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Petrash, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927536
- Sponsor's protocol ID
- 13-0387
- Status last verified
- May 2019
- First submitted
- 2 Aug 2013
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Color Perception Under LED Red/Green and Green Dominant Light
- ClinicalTrials.gov ID
- NCT01927536
- Acronym / sponsor ID
- 13-0387
- Conditions
- Color Blindness, Acquired
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Apr 2013 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 22 Aug 2013 (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.
The investigators are testing a Light-emitting Diode (LED) flashlight from First-Light™ USA called the Tomahawk MC Tactical Light to determine the range of colors people are able to see with these flashlights at night. The flashlight has been designed to reduce visibility of the user and uses a combination of green and red LED lamps to achieve this. In this study investigators wish to determine how well a subject can differentiate colors at night in a quantifiable manner. Investigators will use the Farnsworth Munsell 100 hue test which requires the user to put shades of red, green, blue and yellow into progressive color order which is scored according to the manufactures specifications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Night Vision | – | Device: White LED Flashlight, Device: Red/Green Green Dominant LED FlashlightWhite LED Flashlight, Red/Green Green Dominant LED Flashlight |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal color vision status
Key inclusion criteria (2 listed)
- normal vision
- 18-65 years
Key exclusion criteria (5 listed)
- blindness
- colorblind
- pregnant women
- prisoners
- decisionally challenged
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 |
|---|---|---|
| White LED FlashlightAlso: Tomahawk serial number TMC12420white light setting | Device | Night Vision |
| Red/Green Green Dominant LED FlashlightAlso: Tomahawk serial number TMC12420, green dominant settingGreen LED light dominant setting | Device | Night Vision |
Primary outcome
Change in Normal Color vision
Time frame: 1 hr
The Farnsworth Munsell 100 Hue Test is used to determine normal color vision and vision using the red green Tomahawk LED flashlight.
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 15 May 2019.
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.
Mark Petrash, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Color Blindness, Acquired, run by University of Colorado, Denver at 1 site in United States.
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: finished, as of the sponsor's last update on 15 May 2019. 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 United States. 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?
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 Normal Color vision (time frame: 1 hr). 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 May 2019.