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Enrollment and study activities were terminated due to difficulties with recruitment of participants.
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This study addresses whether the use of EnChroma products are feasible for use in the emergency department by color vision deficient providers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EnChroma glasses | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnChroma glasses | Device | 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.). |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Siegelman, MD | Emory Univer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Hospital | Atlanta | Georgia | 30322 | United States |
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Participants were enrolled between August 2019 and March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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.). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who signed the consent and started study activities.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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.). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Median | Standard Deviation | score on a scale | 2 weeks post-intervention |
|
All adverse events were collected and documented during the duration of study participation= two (2) weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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.). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey N. Siegelman | Emory University | 4042518868 | jsiegelman@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2020 | Jul 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003117 | Color Vision Defects |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| 2 weeks post-intervention |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| 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). | Posted | Median | Standard Deviation | score on a scale | 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). | Posted | Median | Standard Deviation | score on a scale | 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. | Posted | Count of Participants | Participants | 2 weeks post-intervention |
|
|
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| 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. | Posted | Count of Participants | Participants | 2 weeks post-intervention |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D000077765 |
| Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |