Clinical Trial: A Novel Objective Diagnostic Test for Otitis Media With Effusion

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: RGB Measurements as a Novel Objective Diagnostic Test for Otitis Media With Effusion

Brief Summary: Otitis media with effusion (OME) cases refer to a clinically silent condition. Otoscopic findings are subjective and not always reliable. As an objective test tympanometric evaluation is imperfect for diagnosis of OME. The objective of our study was to investigate, in OME cases, the correlation of tympanic membrane color changes with the presence and viscosity of effusion in the middle ear. The study aimed to provide objective diagnostic and therapeutic criteria for patients scheduled for surgery by 2 means: measuring the viscosity of the fluid and evaluating color changes objectively with red-green-blue (RGB) measurements.

Detailed Summary: Endoscopic images of the tympanic membranes of 52 patients (Group 1) and 52 healthy controls (Group 2) were taken during their otologic examinations. All patients in Group 1 had hearing loss and were diagnosed with OME after audiological evaluation. Specific points were designated at certain areas on each tympanic membrane, and RGB values of those specific points were measured on the tympanic membrane images of both groups. Additionally, in Group 1 viscosity of each effusion taken by paracentesis during surgery was also measured intraoperatively with a viscometer. Patients with viscosity values lower than 450 cP (centipoise) were subdivided into Group 1a, and those with values higher than 450 cP into Group 1b.
Sponsor: Nazan Degirmenci

Current Primary Outcome: Mean RGB values [ Time Frame: January-May 2013 (5 months) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bezmialem Vakif University

Dates:
Date Received: May 30, 2014
Date Started: January 2013
Date Completion:
Last Updated: July 1, 2014
Last Verified: January 2013