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

Phase 1

Withdrawn

• Conditions: Thickened Ears; Tympanosclerosis; Surgery; Healthy
• Interventions: Drug: Glycerol

• Registration Number: NCT05497934
• Lead Sponsor: Nova Scotia Health Authority

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.

Study Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-11
• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-03-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Glycerol	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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