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NCT05497934 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05497934
Other study ID # 1028201
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date October 1, 2022
Est. completion date March 31, 2024

Study information
Verified date August 2022
Source Nova Scotia Health Authority
Contact Rob Adamson, PhD
Phone 1-902-497-8579
Email radamson@dal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date March 31, 2024
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Glycerol
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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Nova Scotia Health Authority Dalhousie University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 min
Secondary Change in acoustic mobility of the umbo Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions 20 min
Secondary 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 20 min
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