Evaluation of a Short Wave Infrared Otoscope for Diagnosing Middle Ear Fluid in Children Undergoing Tympanostomy Tube Surgery

What this Trial Is About

Researchers are evaluating a new Short Wave Infrared SWIR otoscope as a diagnostic tool for detecting middle ear infections in children aged 1 to 17 years who are undergoing tympanostomy tube placement surgery. The study aims to provide preliminary data to support future research by comparing the SWIR otoscope with the standard white light otoscope. Otitis media is a common cause for ear infections and tympanostomy tube surgeries, but current diagnosis methods are often subjective and may lead to misdiagnosis or overtreatment. In this study, all participants will have their middle ears imaged using both the SWIR otoscope and the white light otoscope simultaneously during their surgery. The SWIR otoscope records images in AVI format capturing both SWIR and white light data. The presence or absence of middle ear fluid will be confirmed during the standard surgical procedure by fluid removal. The images are then analyzed by a physician and a computer program to assess fluid presence. This comparison will help evaluate the accuracy of the SWIR otoscope. Participants will undergo imaging during their scheduled surgery, with no additional intervention beyond standard care. The study measures the number of accurate diagnoses made by the SWIR otoscope within 30 minutes, confirmed by surgical findings. The involvement includes image analysis and recording during surgery with no extra follow-up beyond the procedure. The total participation period corresponds with the surgical event and imaging process, aiming to improve diagnostic tools for middle ear infections in children.

SWIR Otoscopy Study