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

Phase 1

Withdrawn

• Conditions: Tympanosclerosis; Thickened Ears; Healthy; Surgery

• Registration Number: NCT05497934
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-8-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Thickened tympanic membrane (e.g. due to fibrosis) x10<br><br> - Tympanosclerosis of the tympanic membrane x10<br><br> - History of middle ear surgery with partial or total ossicular replacement prosthesis<br> and cartilage tympanoplasty x10<br><br> - History of cartilage tympanoplasty without prosthesis implantation x10<br><br> - Normal tympanic membrane without history of middle ear disease x10<br><br>Exclusion Criteria:<br><br> - Narrow or stenotic external auditory canal that prevents visualization of the<br> tympanic membrane<br><br> - Mobility disorder that prevents patient from remaining still during imaging<br><br> - Perforation of the tympanic membrane<br><br> - Open sores or infections of the external auditory canal

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in optical attenuation rate of the tympanic membrane

Secondary Outcome Measures

Name	Time	Method
Change in acoustic mobility of the umbo;Change in B-mode signal-to-noise ratio of the cochlear promontorium