The Effects of Glycerol as an Optical Clearing Agent for Visualization of the Middle Ear
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Change in optical attenuation rate of the tympanic membrane
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Glycerol (Drug)
结局指标
主要结局
Change in optical attenuation rate of the tympanic membrane
时间窗: 20 minutes
Change in optical attenuation rate (dB/mm) of the tympanic membrane between the pre-treatment and post-treatment conditions
次要结局
- Change in acoustic mobility of the umbo(20 minutes)
- Change in B-mode signal-to-noise ratio of the cochlear promontorium(20 minutes)