Middle Ear Effusion, Otitis Media
Conditions
Brief summary
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.
Interventions
DEVICELaser otoscope examination
Patients will have short videos taken of their tympanic membranes under white light and laser illumination.
Sponsors
MSTATT LLC
National Institute on Deafness and Other Communication Disorders (NIDCD)
The Cleveland Clinic
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement * Between the ages of 6 months to 18 years at the time of consent * Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection
Exclusion criteria
* History of prior ear tube placement * Anatomical abnormalities of the tympanic membrane or ear canal * Presence of excessive cerumen that cannot be removed pre-exam and may interfere with study procedures * Any of the following deformities of the external ear and tympanic membrane: congenital canal stenosis or atresia, severe canal tortuosity or curvature which prevents visualizing the tympanic membrane fully with an otoscope, canal wall exostoses or osteomas, markedly thickened or opaque tympanic membranes such as caused by chronic myringitis, or scarring or fibrosis of the tympanic membrane, tympanosclerosis or other heavy calcification of the tympanic membrane, tympanic membrane perforations, and grafted tympanic membranes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence | From enrollment to data collection at tympanostomy typically at 2-3 weeks | 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. |
Countries
United States
Outcome results
None listed