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Feasibility of EnChroma Use in the Emergency Department Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04021914
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : July 16, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Siegelman, Emory University

Brief Summary:
This study addresses whether the use of EnChroma products are feasible for use in the emergency department by color vision deficient providers.

Condition or disease Intervention/treatment Phase
Color Vision Defects Device: EnChroma glasses Not Applicable

Detailed Description:
This study addresses whether it is feasible for color vision deficient (CVD) physicians and other healthcare providers to wear EnChroma products in the clinical setting. It is known that color vision is important to the practice of medicine. Identifying red skin or red ear drums, noticing whether lips have turned blue or a patient is pale, and identifying colors under a microscope all are aided by or dependent upon color vision. While color vision deficiency does not preclude a person from becoming and succeeding as a physician, it may be appropriate and desired to utilize devices to improve color vision during patient care.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Demonstrating Feasibility of Color Vision Deficient Provider Use of EnChroma Products in the Emergency Department
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EnChroma glasses
EnChroma products improve brightness and color purity of primary colors for CVD people. Each participant with CVD will be provided EnChroma products to use indoors over the course of two weeks in the emergency department, educational settings, and in their personal life.
Device: EnChroma glasses
Each participant will be provided EnChroma products to use indoors over the course of two weeks in the emergency department, educational settings, and in their personal life. They will be encouraged to wear the glasses for at least 10 hours over 1-2 weeks prior to wearing them in a clinical setting to adjust to their use, and for 10 minutes before beginning patient care as per manufacturer instructions. They will be encouraged to take specific note of clinical scenarios that require the use of color vision (e.g., - rashes, tympanic membrane erythema, stool guaiac testing, etc.).




Primary Outcome Measures :
  1. Change in color vision based on patients' description [ Time Frame: Baseline, 2 weeks ]
    Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision

  2. Change in color vision based on on 100mm scale [ Time Frame: Baseline, 2 weeks ]
    Subjective influence of EnChroma glasses on color vision will be assessed on 100mm scale (higher number indicates more favorable outcome).

  3. Comfort of EnChroma glasses [ Time Frame: 2 weeks follow up ]
    Comfort of EnChroma glasses will be assessed by a multiple choice question, where a respondent can choose from listed responses (e.g., didn't like, uncomfortable) or write a free text


Secondary Outcome Measures :
  1. Impact of the glasses on patient care [ Time Frame: Baseline, 2 weeks ]
    Impact of the glasses on patient care, especially in situations that require the use of color vision (e.g., - rashes, tympanic membrane erythema, stool guaiac testing, etc.), will be assessed by asking a question about the impact, also allowing free text response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • Red-Green color deficiency

Exclusion Criteria:

  • Achromatopsia
  • Cataracts
  • Glaucoma
  • Legal blindness
  • Macular degeneration
  • Retinitis Pigmentosa

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021914


Locations
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United States, Georgia
Emory Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Jeffrey Siegelman, MD Emory Univer
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Responsible Party: Jeffrey Siegelman, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04021914    
Other Study ID Numbers: IRB00111894
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jeffrey Siegelman, Emory University:
CVD
color vision deficiency
healthcare providers
emergency department
Enchroma glasses
Additional relevant MeSH terms:
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Color Vision Defects
Emergencies
Disease Attributes
Pathologic Processes
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Cone Dystrophy
Eye Diseases, Hereditary
Eye Diseases
Signs and Symptoms