Feasibility of middle ear OCT imaging

• Conditions: ear infections; Middle ear diseases; otitis media; 10027584

• Registration Number: NL-OMON51754
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Suspected middle ear problem

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, including:
o Abnormally narrow or stenotic external meatus (ear canal)
o Movement disorder causing inability to keep head still during imaging

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients in which structural OCT imaging was feasible (i.e., the<br /><br>OCT images showed a discernible tympanic membrane (TM) and at least one of the<br /><br>ossicles).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Number of middle ear structures (TM, ossicles) on which OCT-vibrometry<br /><br>measurements by Aurisvue succeeded.<br /><br>- For diagnostic correlation with other clinical data sources (only as far as<br /><br>they are available from the standard of care):<br /><br>o microscopic otoscopy (description)<br /><br>o CT-scan<br /><br>o MRI-scan<br /><br>o pure-tone audiogram<br /><br>o tympanogram<br /><br>o surgical report (if available)</p><br>