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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Tympanosclerosis Thickened Ears Healthy Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will undergo OCT and conventional endoscopic imaging before topical application of glycerol to the tympanic membrane, after topical application of glycerol to the tympanic membrane and after rinsing the tympanic membrane with saline.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Treatment arm

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

Group Type EXPERIMENTAL

Glycerol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Glycerin(e)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes