- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034575
Eye Tracking in Laryngology
A Study to Assess Eye Tracking and Visual Gaze Patterns in Laryngology
Study Overview
Detailed Description
Novice and experienced participants will be recruited to take part in this study. Novices include medical students without practical experience in otorhinolaryngology and resident physicians at different stages in training. Trainees, residents and experts from fields of gastroenterology and pulmonology will also be included. The experienced group will be defined as consultants and speech pathologists.
This study will look at multiple areas within otolaryngology including laryngology, rhinology, facial plastic surgery, head and neck oncology, and otology. Participants will view prerecorded videos and/or still pictures absent of patient identifiers.
There will be two tasks each taking approximately 10 minutes. Task order will be alternated between subjects with one task asking participants to view 7 still images from video laryngoscopy examinations. After each image participants will rate how likely the image is to represent glottic cancer and what portion of the image they deemed most important to their decision. For the second task, participants will be asked to view a 5 second video of a flexible laryngoscope exam, after which, they will be asked to identify the presence and side of vocal fold paralysis as well as note the location they deemed most important to their decision.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults, age 18 and over.
- Already professionals in a laryngology related field, residents in a related field or students considering a related field.
- Related fields include otolaryngology, laryngology, and speech language pathology.
Exclusion Criteria:
- Anyone not meeting the inclusion criteria or anyone not wishing to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Novice and experienced medical personnel
Participants will be asked to complete two tasks each taking approximately 10 minutes while wearing eye-tracking technology to understand focus of gaze during laryngeal endoscopy and stroboscopy interpretation.
|
Eye tracking will be performed using Tobii Pro eye tracking technology sensor (Tobii Pro Fusion, Stockholm, Sweden), providing binocular eye tracking up to 250 Hz.
The sensor, positioned on the inferior aspect of the computer monitor, reflects infrared (IR) light beams off of each cornea and are subsequently captured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Fixation Fixation Point
Time Frame: 15 minutes
|
Defined as the temporary suspension of eye movement (80ms) on a specific point (≤ 30 pixels) within the field of view.
|
15 minutes
|
|
Percent of Fixation Time on pre determined area of interest
Time Frame: 15 minutes
|
Defined as the percent of total gaze time on area of interest
|
15 minutes
|
|
Count of Fixations
Time Frame: 15 minutes
|
Number of times observer returns gaze to area of interest
|
15 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Diana Orbelo, PhD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-012365
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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