Tympanosclerosis, Thickened Ears, Healthy, Surgery
Conditions
Brief summary
This study will examine the improvement in middle ear optical coherence tomography imaging from the topical application of glycerol to the tympanic membrane in normal, opaque and post-operative ears
Detailed description
This study will explore whether the utility of Optical Coherence Tomography (OCT) in otology patients can be enhanced through the application of topical glycerol as an optical clearing agent in patients with normal, opaque and post operative tympanic membranes. In each group of subjects, a comparison will be made between OCT images obtained before and after the topical application of glycerol to the tympanic membrane and following washout with saline. Images will also be assessed for their diagnostic utility as determined by the visibility of key structures and the change in middle ear mobility caused by glycerol absorption in the tympanic membrane.
Interventions
DRUGGlycerol
In this study, 99.5% pure glycerol will be used as an optical clearing agent. The glycerol will be applied topically to the tympanic membrane.
Sponsors
Dalhousie University
Nova Scotia Health Authority
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All subjects will undergo OCT and conventional endoscopic imaging before topical application of glycerol to the tympanic membrane, after topical application of glycerol to the tympanic membrane and after rinsing the tympanic membrane with saline.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Thickened tympanic membrane (e.g. due to fibrosis) x10 * Tympanosclerosis of the tympanic membrane x10 * History of middle ear surgery with partial or total ossicular replacement prosthesis and cartilage tympanoplasty x10 * History of cartilage tympanoplasty without prosthesis implantation x10 * Normal tympanic membrane without history of middle ear disease x10
Exclusion criteria
* Narrow or stenotic external auditory canal that prevents visualization of the tympanic membrane * Mobility disorder that prevents patient from remaining still during imaging * Perforation of the tympanic membrane * Open sores or infections of the external auditory canal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in optical attenuation rate of the tympanic membrane | 20 minutes | Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in acoustic mobility of the umbo | 20 minutes | Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions |
| Change in B-mode signal-to-noise ratio of the cochlear promontorium | 20 minutes | Change in the B-mode signal-to-noise ratio for a region of interest on the cochlear promontorium distal to the tympanic membrane between pre- and post-treatment conditions |
Outcome results
None listed