Evaluating Color Perception Under LED Red/Green and Green... | NCT01927536

Studies
Evaluating Color Perception Under LED Red/Green and Green Dominant Light

NCT01927536

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

May 15, 2019Actual

Enrollment

39Actual

Phase

Not provided

Conditions

Color Blindness, Acquired

Interventions

White LED Flashlight
Red/Green Green Dominant LED Flashlight

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2013Actual

Primary Completion Date

Jan 10, 2019Actual

Completion Date

Jan 10, 2019Actual

First Submitted Date

Aug 2, 2013

First Submission Date that Met QC Criteria

Aug 19, 2013

First Posted Date

Aug 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2019

Last Update Posted Date

May 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Night Vision		White LED Flashlight, Red/Green Green Dominant LED Flashlight	Device: White LED Flashlight Device: Red/Green Green Dominant LED Flashlight

Interventions

Name	Type	Description	Arm Group Labels	Other Names
White LED Flashlight	Device	white light setting	Night Vision	Tomahawk serial number TMC12420

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 hr

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal vision
18-65 years

Exclusion Criteria:

blindness
colorblind
pregnant women
prisoners
decisionally challenged

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

Normal color vision status

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Petrash, PhD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Dept of Opthalmology		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D003117	Color Vision Defects

Ancestor Terms

ID	Term
D014786	Vision Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided