Middle Ear Disease
Conditions
Brief summary
The aim of this study is to understand the diagnostic applications for this imaging technology and identify particular disorders to target for future clinical investigations. Images obtained with the Ossiview device will be correlated to other standard of care (SoC) testing including microscopic otoscopy, CT scans, MRIs, audiologic testing results, and surgical and pathology reports.
Detailed description
Optical Coherence Tomography (OCT) is an optical imaging technique that uses a low-coherence interferometer to produce depth-resolved scans in tissue. This study will explore the utility of this technology in otology patients presenting with various pathologies as well as normal subjects.
Interventions
DEVICEOssiview
Imaging of the ear using Optical Coherence Tomography
Sponsors
University of Arkansas
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years * Ability to understand the consent process with adequate language and cognitive communication ability * Presence of one of the pathologies (either currently or in the past) above or healthy control
Exclusion criteria
* Narrow or stenotic external meatus (ear canal) * Movement disorder causing inability to keep head still during imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic correlation with microscopic otoscopy | 6 months | Comparison of Diagnostic ability to other standard of care (SoC) testing - microscopic otoscopy |
| Diagnostic correlation with CT scans | 6 months | Comparison of Diagnostic ability to other standard of care (SoC) testing - CT scans |
| Diagnostic correlation with Magnetic Resonance Imaging (MRI)s | 6 months | Comparison of Diagnostic ability to other standard of care (SoC) testing - MRIs |
| Diagnostic correlation with audiologic testing results | 6 months | Comparison of Diagnostic ability to other standard of care (SoC) testing - audiologic testing results |
| Diagnostic correlation with surgical reports | 6 months | Comparison of Diagnostic ability to other standard of care (SoC) testing - surgical reports |
| Diagnostic correlation with pathology reports | 6 months | Comparison of Diagnostic ability to other standard of care (SoC) testing - pathology reports |
Countries
United States
Outcome results
None listed