Cholesteatoma otitis media, chronic otitis media, severe sensorineural hearing loss, facial nerve palsy, Meniere'
Conditions
Interventions
Among consented patients who are randomized to the AR-supported arm, the following support will be provided. In the operating room, a display mirroring the head-mounted display (HMD) field of view wil
Sponsors
Institute Of Science Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who require surgical treatment for cholesteatoma, chronic otitis media, facial nerve palsy, severe hearing loss, Meniere's disease, external auditory canal carcinoma, or chronic rhinosinusitis and who provide informed consent.
Exclusion criteria
Exclusion criteria: Individuals who cannot personally provide informed consent. Individuals with impaired capacity to make an independent decision about participation, or minors (<20 years of age). Any other individuals deemed unsuitable for participation by the principal investigator or co-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation will be based on a postoperative questionnaire, with cognitive workload measured using the NASA Task Load Index (NASA-TLX). As a secondary endpoint, operative time will be assessed. Statistical analysis: * Subjective measures (NASA-TLX) will be compared between groups using a mixed-effects model. * Operative time will be analyzed with a model that includes fixed effects for the intervention (AR guidance present vs absent), surgeon, and procedure. Results will be reported as time ratios (geometric mean ratios) with 95% confidence intervals. | — |
Countries
Japan
Contacts
Public ContactYoshimaru Mizoguchi
Institute of Science Tokyo Department of Otorhinolaryngology
Outcome results
None listed