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

Sponsor
Nova Scotia Health Authority (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05497934
Collaborator
Dalhousie University (Other)
50
Enrollment
1
Arm
18
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in optical attenuation rate of the tympanic membrane [20 min]

      Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions

    Secondary Outcome Measures

    1. Change in acoustic mobility of the umbo [20 min]

      Change in the mobility (mm/s/Pa) of the umbo between pre- and post-treatment conditions

    2. Change in B-mode signal-to-noise ratio of the cochlear promontorium [20 min]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nova Scotia Health Authority
    • Dalhousie University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Adamson, Affiliated Scientist, Nova Scotia Health Authority
    ClinicalTrials.gov Identifier:
    NCT05497934
    Other Study ID Numbers:
    • 1028201
    First Posted:
    Aug 11, 2022
    Last Update Posted:
    Aug 11, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Myringosclerosis
    Glycerol

    Study Results

    No Results Posted as of Aug 11, 2022