The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear

Nova Scotia Health Authority

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Tympanosclerosis Thickened Ears Healthy Surgery

Interventions

GlycerolDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 20 minutes

Secondary Outcomes

Change in acoustic mobility of the umbo

Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions

Time frame: 20 minutes

Change in B-mode signal-to-noise ratio of the cochlear promontorium

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

Time frame: 20 minutes

Data from ClinicalTrials.gov

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