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

Nova Scotia Health Authority (NSHA)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy; Thickened Ears; Surgery; Tympanosclerosis

Treatments: Drug: Glycerol

Study type: Interventional

Funder types: Other

Identifiers

NCT05497934

1028201

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment arm

Experimental group

Description:

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

Treatment:

Drug: Glycerol