Color Vision DefectsNCT04021914
Feasibility of EnChroma Use in the Emergency Department Setting
A study testing EnChroma glasses in people with Color Vision Defects, run by Emory University at 1 site in United States.
Trial summary
This study addresses whether the use of EnChroma products are feasible for use in the emergency department by color vision deficient providers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Color Vision Defects
- What is being tested?
- EnChroma glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Red-Green color deficiency
Who cannot join
- Achromatopsia
- Cataracts
- Glaucoma
- Legal blindness
- Macular degeneration
- Retinitis Pigmentosa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Color Vision Defects
- Being tested
- EnChroma glasses
- Keywords
- CVD, color vision deficiency, healthcare providers, emergency department, Enchroma glasses
- Medical subject headings
- Color Vision Defects, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnChroma glassesDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EnChroma glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 2 weeks post-intervention
Secondary outcomes (1)
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.
Measured: 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start14 Aug 2019
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Why it stopped: Enrollment and study activities were terminated due to difficulties with recruitment of participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Color Vision DefectsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Siegelman, Emory University
- Investigators
- Jeffrey Siegelman, MD, Principal investigator, Emory Univer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021914
- Sponsor's protocol ID
- IRB00111894
- Status last verified
- Aug 2023
- First submitted
- 13 Jul 2019
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstrating Feasibility of Color Vision Deficient Provider Use of EnChroma Products in the Emergency Department
- ClinicalTrials.gov ID
- NCT04021914
- Acronym / sponsor ID
- IRB00111894
- Conditions
- Color Vision Defects
- Keywords
- CVD, color vision deficiency, healthcare providers, emergency department, Enchroma glasses
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment and study activities were terminated due to difficulties with recruitment of participants.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EnChroma glasses | Experimental | Device: EnChroma glassesEnChroma 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Red-Green color deficiency
Key exclusion criteria (6 listed)
- Achromatopsia
- Cataracts
- Glaucoma
- Legal blindness
- Macular degeneration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnChroma glassesEach 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.). | Device | EnChroma glasses |
Primary outcome
Overall Quality of Color Vision Perception Based on Patients' Description
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Number of Participants That Reported an Impact of Using the Glasses on Patient Care
Time frame: 2 weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Siegelman, MD principal investigator
Emory Univer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnChroma glasses in people with Color Vision Defects, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Quality of Color Vision Perception Based on Patients' Description (time frame: 2 weeks post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.