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No response from initial letter or expiry email- closed by REB office
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| Name | Class |
|---|---|
| Dalhousie University | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Subjects will be imaged with OCT and endoscopy before treatment of the tympanic membrane with topical glycerol, after treatment of the tympanic membrane with topical glycerol and after rinsing the tympanic membrane with saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerol | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in optical attenuation rate of the tympanic membrane | Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in acoustic mobility of the umbo | Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions | 20 minutes |
| Change in B-mode signal-to-noise ratio of the cochlear promontorium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Morris, MD | Nova Scotia Health Authority | Principal Investigator |
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Results of trial will be published in a journal article
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| ID | Term |
|---|---|
| D000092163 | Tympanosclerosis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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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.
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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
| 20 minutes |
| D002241 |
| Carbohydrates |