Feasibility of EnChroma Use in the Emergency Department Setting
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04021914|
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : July 16, 2019
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Color Vision Defects||Device: EnChroma glasses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Demonstrating Feasibility of Color Vision Deficient Provider Use of EnChroma Products in the Emergency Department|
|Actual Study Start Date :||August 14, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
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.).
- Change in color vision based on patients' description [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- Impact of the glasses on patient care [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04021914
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Jeffrey Siegelman, MD||Emory Univer|