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
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy
• Surgery

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