Feasibility of EnChroma Use in the Emergency Department Setting

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04021914

Collaborator

(none)

Enrollment

Location

Arm

33.6

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Color Vision Defects	Device: EnChroma glasses	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 14, 2019

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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.).

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.).

Outcome Measures

Primary Outcome Measures

Change in color vision based on patients' description [Baseline, 2 weeks]
Subjective influence of EnChroma glasses will be assessed by asking to describe a difference that the glasses made in color vision
Change in color vision based on on 100mm scale [Baseline, 2 weeks]
Subjective influence of EnChroma glasses on color vision will be assessed on 100mm scale (higher number indicates more favorable outcome).
Comfort of EnChroma glasses [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

Impact of the glasses on patient care [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-65
Red-Green color deficiency

Exclusion Criteria:

Achromatopsia
Cataracts
Glaucoma
Legal blindness
Macular degeneration
Retinitis Pigmentosa

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator: Jeffrey Siegelman, MD, Emory Univer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey Siegelman, Principal Investigator, Emory University

ClinicalTrials.gov Identifier:

NCT04021914

Other Study ID Numbers:

IRB00111894

First Posted:

Jul 16, 2019

Last Update Posted:

Sep 30, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Jeffrey Siegelman, Principal Investigator, Emory University

CVD

color vision deficiency

healthcare providers

emergency department

Enchroma glasses

Additional relevant MeSH terms:

Color Vision Defects

Emergencies

Study Results

No Results Posted as of Sep 30, 2021