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Feasibility of EnChroma Use in the Emergency Department Setting

Primary Purpose

Color Vision Defects

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EnChroma glasses
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Color Vision Defects focused on measuring CVD, color vision deficiency, healthcare providers, emergency department, Enchroma glasses

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-65
  • Red-Green color deficiency

Exclusion Criteria:

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

Sites / Locations

  • Emory Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EnChroma glasses

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Quality of Color Vision Perception Based on Patients' Description
Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision. The overall quality of color perception will be assessed with a scale from 1 to 10. Higher score correlates highest quality (better outcome).
Overall Quality of Color Vision Perception in Normal Daylight Based on Patients' Description
Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision perception in normal daylight based on patients' description. The overall quality of color perception will be assessed with a scale from 1 to 10. Higher score correlates highest quality (better outcome).
Overall Quality of Color Vision Perception in Dim Light Based on Patients' Description
Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision perception in dim light based on patients' description. The overall quality of color perception will be assessed with a scale from 1 to 10. Higher score correlates highest quality (better outcome).
Number of Participants Reporting More Positive Than Negative Comments About the Use of the EnChroma Glasses
Comfort of EnChroma glasses will be assessed by a multiple choice question, where a respondent can choose from listed negative or positive responses (e.g., did or didn't like, comfortable or uncomfortable, ). Number of participants reporting more positive than negative comments about the use of the EnChroma glasses will be reported.

Secondary Outcome Measures

Number of Participants That Reported an Impact of Using the Glasses on Patient Care
Number of participants that reported an 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. Participants that report impact is associated with better outcome.

Full Information

First Posted
July 13, 2019
Last Updated
August 22, 2023
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT04021914
Brief Title
Feasibility of EnChroma Use in the Emergency Department Setting
Official Title
Demonstrating Feasibility of Color Vision Deficient Provider Use of EnChroma Products in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Enrollment and study activities were terminated due to difficulties with recruitment of participants.
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Color Vision Defects
Keywords
CVD, color vision deficiency, healthcare providers, emergency department, Enchroma glasses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EnChroma glasses
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EnChroma glasses
Intervention Description
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 Measure Information:
Title
Overall Quality of Color Vision Perception Based on Patients' Description
Description
Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision. The overall quality of color perception will be assessed with a scale from 1 to 10. Higher score correlates highest quality (better outcome).
Time Frame
2 weeks post-intervention
Title
Overall Quality of Color Vision Perception in Normal Daylight Based on Patients' Description
Description
Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision perception in normal daylight based on patients' description. The overall quality of color perception will be assessed with a scale from 1 to 10. Higher score correlates highest quality (better outcome).
Time Frame
2 weeks post-intervention
Title
Overall Quality of Color Vision Perception in Dim Light Based on Patients' Description
Description
Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision perception in dim light based on patients' description. The overall quality of color perception will be assessed with a scale from 1 to 10. Higher score correlates highest quality (better outcome).
Time Frame
2 weeks post-intervention
Title
Number of Participants Reporting More Positive Than Negative Comments About the Use of the EnChroma Glasses
Description
Comfort of EnChroma glasses will be assessed by a multiple choice question, where a respondent can choose from listed negative or positive responses (e.g., did or didn't like, comfortable or uncomfortable, ). Number of participants reporting more positive than negative comments about the use of the EnChroma glasses will be reported.
Time Frame
2 weeks post-intervention
Secondary Outcome Measure Information:
Title
Number of Participants That Reported an Impact of Using the Glasses on Patient Care
Description
Number of participants that reported an 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. Participants that report impact is associated with better outcome.
Time Frame
2 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 Red-Green color deficiency Exclusion Criteria: Achromatopsia Cataracts Glaucoma Legal blindness Macular degeneration Retinitis Pigmentosa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Siegelman, MD
Organizational Affiliation
Emory Univer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility of EnChroma Use in the Emergency Department Setting

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