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

August 19, 2024 updated by: Nova Scotia Health Authority
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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Other Names:
  • Glycerin(e)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in optical attenuation rate of the tympanic membrane
Time Frame: 20 minutes
Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in acoustic mobility of the umbo
Time Frame: 20 minutes
Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions
20 minutes
Change in B-mode signal-to-noise ratio of the cochlear promontorium
Time Frame: 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
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: David P Morris, MD, Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2022

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1028201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Results of trial will be published in a journal article

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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