Feasibility of middle ear OCT imaging

Feasibility of middle ear OCT imaging - Feasibility of middle ear OCT imaging

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51754

Enrollment

100

Registered

2022-11-25

Start date

2022-10-24

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

ear infections Middle ear diseases otitis media

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Suspected middle ear problem

Exclusion criteria

Exclusion criteria: Any acute or chronic condition that would limit the ability of the patient to participate in the study, per attending physician*s indication, including: o Abnormally narrow or stenotic external meatus (ear canal) o Movement disorder causing inability to keep head still during imaging

Design outcomes

Primary

Measure	Time frame
Percentage of patients in which structural OCT imaging was feasible (i.e., the OCT images showed a discernible tympanic membrane (TM) and at least one of the ossicles).	—

Secondary

Measure	Time frame
- Number of middle ear structures (TM, ossicles) on which OCT-vibrometry measurements by Aurisvue succeeded. - For diagnostic correlation with other clinical data sources (only as far as they are available from the standard of care): o microscopic otoscopy (description) o CT-scan o MRI-scan o pure-tone audiogram o tympanogram o surgical report (if available)	—

Countries

Netherlands

Outcome results