Diagnosis Clinical Trial
— otoscopyOfficial title:
Comparison of Efficacy in Diagnosing of Middle Ear Pathology Between Digital Otoscope and Otoendoscope.
Verified date | August 2023 |
Source | Chiang Mai University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Otolaryngology Faculty of Medicine, Chiang Mai University 110 Intawaroros Road, Sriphum | Chiang Mai |
Lead Sponsor | Collaborator |
---|---|
Chiang Mai University |
Thailand,
Bhavana K, Ahmad M, Sharma P. Smartphone Otoscopy Sans Attachment: A Paradigm Shift in Diagnosing Ear Pathologies. OTO Open. 2018 Jul 19;2(3):2473974X18786496. doi: 10.1177/2473974X18786496. eCollection 2018 Jul-Sep. — View Citation
Chan KN, Silverstein A, Bryan LN, McCracken CE, Little WK, Shane AL. Comparison of a Smartphone Otoscope and Conventional Otoscope in the Diagnosis and Management of Acute Otitis Media. Clin Pediatr (Phila). 2019 Mar;58(3):302-306. doi: 10.1177/0009922818 — View Citation
Moshtaghi O, Sahyouni R, Haidar YM, Huang M, Moshtaghi A, Ghavami Y, Lin HW, Djalilian HR. Smartphone-Enabled Otoscopy in Neurotology/Otology. Otolaryngol Head Neck Surg. 2017 Mar;156(3):554-558. doi: 10.1177/0194599816687740. Epub 2017 Jan 24. — View Citation
Mousseau S, Lapointe A, Gravel J. Diagnosing acute otitis media using a smartphone otoscope; a randomized controlled trial. Am J Emerg Med. 2018 Oct;36(10):1796-1801. doi: 10.1016/j.ajem.2018.01.093. Epub 2018 Jan 31. — View Citation
Rappaport KM, McCracken CC, Beniflah J, Little WK, Fletcher DA, Lam WA, Shane AL. Assessment of a Smartphone Otoscope Device for the Diagnosis and Management of Otitis Media. Clin Pediatr (Phila). 2016 Aug;55(9):800-10. doi: 10.1177/0009922815593909. Epub — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology | agreement percentage | 6 months | |
Primary | efficacy of digital otoscope and otoendoscope in diagnosis of middle ear pathology | Cohen's kappa coefficient | 6 months |
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