A Novel Objective Diagnostic Test for Otitis Media With Effusion

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02179541
Study type	Observational
Source	Bezmialem Vakif University
Contact
Status	Completed
Phase	N/A
Start date	January 2013
Completion date	May 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03590912` - Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion	Phase 4
Completed	`NCT03611842` - Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
Not yet recruiting	`NCT01421199` - Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children	N/A
Completed	`NCT01202578` - Evaluation of the Tympanostomy Tube Delivery System	Phase 2/Phase 3
Completed	`NCT00629694` - Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy	Phase 2
Completed	`NCT00520039` - Osteopathic Otitis Media Research Study	N/A
Completed	`NCT00195611` - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media	Phase 4
Not yet recruiting	`NCT05402267` - The Effects of Exosomes in Otitis Media With Effusion
Not yet recruiting	`NCT04584073` - Secretory Otitis Media in Adenoids Hypertrophy Patients	N/A
Withdrawn	`NCT00736112` - Food Allergy - Tubes - Adenoids (FATA) Trial	N/A
Completed	`NCT00546117` - A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion	N/A
Withdrawn	`NCT02950311` - Xylitol for Otitis Media	Phase 2/Phase 3
Recruiting	`NCT05324696` - Autoinflation: Alternative in the Treatment of Otitis Media With Effusion	N/A
Recruiting	`NCT05353569` - Coherent Optical Detection of Middle Ear Disease	N/A
Completed	`NCT02282540` - Novel Imaging of the Eustachian Tube; Patient Study	N/A
Not yet recruiting	`NCT03491098` - The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study	Early Phase 1
Completed	`NCT01082029` - Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children	Phase 4
Completed	`NCT00939796` - Clinical Study of the Tympanostomy Tube Delivery System	N/A
Recruiting	`NCT06316635` - Microplastics in Otitis Media With Effusion Material
Recruiting	`NCT02215681` - Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study	N/A