Feasibility of Middle Ear OCT Imaging

Not Applicable

• Conditions: Image, Body
• Interventions: Device: Aurisvue

• Registration Number: NCT05445388
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06
• Study Start: 2022-08-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCT imaging	Aurisvue	OCT imaging

Primary Outcome Measures

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

Secondary Outcome Measures

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