Feasibility of Middle Ear OCT Imaging

Study Overview
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Brief Summary
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Feasibility of structural and functional imaging of the middle ear and its constituents by optical coherence tomography.

Detailed Description
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Rationale: Various middle ear diseases can affect anatomical structures of the middle ear in different ways. Unfortunately, current methods for assessing the structure and function of the constituents of the middle ear are limited and often fail to provide all clinically relevant data. Optical coherence tomography (OCT) is a technology that can provide valuable, additional information with a newly developed prototype OCT-device for structural and functional imaging of the middle ear. Objective: To assess the feasibility and the clinical potential of structural and functional OCT imaging with a newly developed OCT-device in patients with various middle ear problems. Study design: Observational study Study population: Adult patients presenting with various middle ear complaints at the Ear Nose Throat department of the Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus Medical Center, Rotterdam, the Netherlands. Main study parameters/endpoints: Percentage of patients in which structural OCT imaging was feasible (i.e., the OCT images showed a discernible tympanic membrane (TM) and at least one of the ossicles). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden is minimal: patient examination with Aurisvue is similar to the conventional examination with a standard otoscope and will take approximately 5 to 10 minutes. The risks are negligible: imaging is done with light levels well below the maximum permissible exposure level and sound levels to induce movement of the TM and the ossicular chain are well below the hazardous threshold.

Official Title
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Feasibility of Structural and Functional Imaging of the Middle Ear and Its Constituents by Optical Coherence Tomography

Conditions
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Image, Body

Intervention / Treatment
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* Device: Aurisvue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older competent, willing and able to cooperate Exclusion Criteria: any acute or chronic condition that would limit the ability of the patient to participate in the study, per attending physician's indication refusal to give informed consent pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT imaging<br>OCT imaging | Device: Aurisvue<br>* OCT imaging of the middle ear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Middle ear structures identified with the Aurisvue OCT device | Identification of each of the following anatomical middle ear structures with Aurisvue: tympanic membrane, malleus, incus, stapes and promontory (visible or not visible) | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT-vibrometry measurements with the Aurisvue OCT device | Number of middle ear structures (tympanic membrane, malleus, incus and stapes) on which OCT-vibrometry measurements by Aurisvue succeeded. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Middle Ear