Feasibility of EnChroma Use in the Emergency Department Setting

NCT04021914 | Terminated Results FDA Device

• 1 other identifier: IRB00111894
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Color Vision Defects

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Number of Participants That Reported an Impact of Using the Glasses on Patient Care

  2 weeks post-intervention

Study Arms (1)

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.

Device: EnChroma glasses

Interventions

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.).

EnChroma glasses

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Red-Green color deficiency

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Color Vision Defects; Emergencies

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Dr. Jeffrey N. Siegelman
• Organization: Emory University

jsiegelman@emory.edu

4042518868

Study Officials

• Jeffrey Siegelman, MD

  Emory Univer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 16, 2019
• Study Start: August 14, 2019
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)