NCT05497934

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Tympanosclerosis
• Thickened Ears
• Healthy
• Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-10-01
• Completion: 2024-03-31
• First posted: 2022-08-11
• Last updated: 2024-08-21