Feasibility of EnChroma Use in the Emergency Department Setting

Color Vision Defects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04021914
• Other study ID #: IRB00111894
• Status: Terminated
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: March 15, 2023

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65

• Red-Green color deficiency

Exclusion Criteria:

• Achromatopsia

• Cataracts

• Glaucoma

• Legal blindness

• Macular degeneration

• Retinitis Pigmentosa

Related Conditions & MeSH terms

• Color Vision Defects
• Emergencies

Intervention

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.).

Locations

Country	Name	City	State
United States	Emory Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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