跳至主要内容
临床试验/NCT05620264
NCT05620264招募中不适用

Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment

Johannes Kepler University of Linz1 个研究点 分布在 1 个国家目标入组 392 人开始时间: 2022年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
392
试验地点
1
主要终点
TNF Alpha in Tear Film

研究概览

简要总结

As conventional corneal scraping with bacterial culturing has several disadvantages such as long duration until diagnosis, invasiveness and lacks alternatives, there is demand for a novel non-invasive, rapid test in keratitis management. First aim of this study will be to evaluate the influence of TNF-alpha on Gram+ and Gram- bacteria causing keratitis. Second aim of this study will be to develop an algorithm, that should help to distinguish between different pathogens causing keratitis.

详细描述

Infectious or inflammatory processes of the cornea (keratitis) are common and vision threatening. They are the 5th leading cause of blindness and especially infectious keratitis is responsible for 2,000,000 new blind eyes per year (worldwide). Commonly, the presence and nature of bacterial pathogens is determined by taking scratches from the cornea, subsequent Gram stain and examination of microbiological cultures. Major problems in therapeutic decision-making pose the long duration of bacterial culturing for pathogen detection (approximately one week), relatively low sensitivity and increasingly frequent bacterial resistances to antibiotic agents.

In small previous studies optical coherence tomography (OCT) combined with analysis of tear cytokines were found to be supportive in distinguishing between different pathogens causing keratitis. These studies appear to be a game changer in the field of rapid testing for keratitis. However, the problem of these studies is a small sample size and the use of partially outdated equipment.

Benefit/risk assessment Although there is no direct benefit for participating subjects, the results of the study can help to gain more insight into the course of keratitis and could further improve the diagnostic utilities in disease management.

There is no additional medication used in this study. The findings of the present study could help to establish a better understanding of keratitis and could enable faster and target-oriented therapy. All applied measurement techniques are painfree.

Thus, the risk to benefit ratio seems to be acceptable.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 119 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women age of at least 18 years to 119 years
  • Written informed consent prior to study-related procedures
  • First presentation with keratitis (corneal epithelial ulceration, corneal edema and/or stromal infiltration with inflammatory cells) within 10 days.
  • Untreated keratitis or keratitis not responding to the given treatment

排除标准

  • Subjects will be excluded if one or more of the following criteria apply:
  • Symptoms for more than 10 days
  • Presence or history of a severe medical condition as judged by the clinical investigator
  • Pregnancy, planned pregnancy or lactating

结局指标

主要结局

TNF Alpha in Tear Film

时间窗: The measurement is assessed at the point of study inclusion.

Comparison of TNF-alpha level differences in tear film between Gram+ and Gram- bacteria causing keratitis

次要结局

  • Anterior segment Optical Coherence Tomography(The measurement is assessed at the point of study inclusion)
  • Interleukins(The measurement is assessed at the point of study inclusion.)

研究者

发起方
Johannes Kepler University of Linz
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验