Efficacy of Digital Otoscope and Otoendoscope for Diagnosis of Middle Ear Pathology

Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05813119

Acronym

otoscopy

Enrollment

Registered

2023-04-14

Start date

2022-07-01

Completion date

2023-01-31

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, Middle Ear Disease

Keywords

Middle Ear Disease, otoscope, Diagnosis

Brief summary

For diagnosis of external and middle ear diseases, an otoscope is a key instrument to use. A microscope has been used as a reference standard to confirm pathology. An endoscope has been also widely used. Both microscope and endoscope provide an excellent image quality, can record and capture the images, and the images can be visualized with an export system. A digital otoscope is widely available and more affordable. A comparative study of the efficacy of the endoscope and the digital endoscope will be performed.

Detailed description

A comparative study for the diagnosis of middle ear disease usingTeslong digital otoscope, model MS450D39, and the otoendoscope will be performed. The participants will be recruited at the ENT clinic, University Hospital. A handheld otoscope will be used to identify the patients who have the pathology of the middle ear. The images will be captured with both endoscopes and will be reviewed by staff, residents training in ENT, and residents training in ENT and family medicine.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients who were diagnosed with middle ear disease after examination by conventional otoscope at ENT clinic, Chiang Mai University Hospital * Had otoscopic examination with both digital otoscope and otoendoscope in the same visit in one ear or both ears

Exclusion criteria

* Having abnormal external ear canals such as external auditory canal stenosis, otitis external, otomycosis, or pus/ debris in the ear canal that obscures the view of the eardrum * Changing the pathology of the ear canal or middle ear in the same visit * Trauma after otoscopic examination * can not record or focus the entire view of the eardrum by both otoscopes

Design outcomes

Primary

Measure	Time frame	Description
efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology	6 months	agreement percentage

Countries

Thailand

Outcome results