Feasibility of EnChroma Use in the Emergency Department Setting

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04021914

Enrollment

Registered

2019-07-16

Start date

2019-08-14

Completion date

2023-03-15

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Color Vision Defects

Keywords

CVD, color vision deficiency, healthcare providers, emergency department, Enchroma glasses

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.

Interventions

DEVICEEnChroma 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.).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18-65 * Red-Green color deficiency

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Quality of Color Vision Perception Based on Patients' Description	2 weeks post-intervention	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	2 weeks post-intervention	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	2 weeks post-intervention	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	2 weeks post-intervention	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

Measure	Time frame	Description
Number of Participants That Reported an Impact of Using the Glasses on Patient Care	2 weeks post-intervention	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.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled between August 2019 and March 2023.

Participants by arm

Arm	Count
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. 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.).	5
Total	5

Arm

Count

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. 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.).

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Did not meet inclusion criteria on confirmatory testing	1

Baseline characteristics

Characteristic	EnChroma Glasses
Age, Continuous	45.4 years STANDARD_DEVIATION 9
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants
Race (NIH/OMB) White	0 Participants
Region of Enrollment United States	5 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 5
other Total, other adverse events	0 / 5
serious Total, serious adverse events	0 / 5

Outcome results

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.