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

NCT05497934 | Withdrawn Phase 1

• 1 other identifier: 1028201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Tympanosclerosis; Thickened Ears; Healthy; Surgery

Outcome Measures

Primary Outcomes (1)

• Change in optical attenuation rate of the tympanic membrane

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

  20 minutes

Secondary Outcomes (2)

• Change in acoustic mobility of the umbo

  20 minutes

• Change in B-mode signal-to-noise ratio of the cochlear promontorium

  20 minutes

Study Arms (1)

Treatment arm

EXPERIMENTAL

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

Interventions

Glycerol 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.

Also known as: Glycerin(e)

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Dalhousie University: collaborator

MeSH Terms

Conditions

Tympanosclerosis

Interventions

Glycerol

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• David P Morris, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 11, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: March 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share