Feasibility of EnChroma Use in the Emergency Department Setting

Demonstrating Feasibility of Color Vision Deficient Provider Use of EnChroma Products in the Emergency Department

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

Study Overview

• Status: Terminated
• Conditions: Color Vision Defects
• Intervention / Treatment: Device: EnChroma glasses

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-65
• Red-Green color deficiency

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 weeks post-intervention
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).	2 weeks post-intervention
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).	2 weeks post-intervention
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.	2 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks post-intervention

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Jeffrey Siegelman, MD, Emory Univer

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2019
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: July 13, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: emergency department; CVD; color vision deficiency; healthcare providers; Enchroma glasses
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Disease Attributes; Eye Diseases, Hereditary; Sensation Disorders; Vision Disorders; Cone Dystrophy; Emergencies; Color Vision Defects
• Other Study ID Numbers: IRB00111894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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