A Novel Objective Diagnostic Test for Otitis Media With Effusion

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.

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with OME, that had endoscopic-otoscopic examination findings and type-B tympanograms.
They were all scheduled for ventilation tube insertion.

Exclusion criteria

Patients presenting with acute otitis media, tympanosclerotic plaques, mental retardation, and children who were difficult to cooperate with.

Treatment and study plan

RGB

Other

When a circular area of 30 surrounding pixels are placed exactly upon the above-mentioned standardized points, the Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in that area. The RGB values of the same points on the tympanic membrane images of the two groups were obtained and compared. Diagnostic significance of objectively assessed color changes at the tympanic membrane in OME patients was evaluated.

Primary outcomes

Mean RGB values

Time frame: January-May 2013 (5 months)

Sponsors and collaborators

Lead sponsor

Nazan Degirmenci

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jul 2, 2014
Registry last updated: Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed