The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are: -Accuracy and usability of doctors using laser otoscopes Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
Study Type
OBSERVATIONAL
Enrollment
150
Patients will have short videos taken of their tympanic membranes under white light and laser illumination.
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence
The primary endpoint is the accuracy, PPV, and NPV of the MEEscope in detecting MEE validated by myringotomy findings. These values will be compared to the standard white-light otoscopy findings in the same patients to demonstrate the relative accuracy of the experimental illumination vs white light illumination in detection of MEE.
Time frame: From enrollment to data collection at tympanostomy typically at 2-3 weeks
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