Diagnosis of Microbial Keratitis Using Corneal Impression Membrane
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
Microbial keratitis is a common and serious eye disease in Edinburgh. Prompt treatment with antibiotics can prevent sight loss, and identification of the micro-organism and its antibiotic sensitivities are key to appropriate management. Standard practice of collecting infected material from the cornea using a blade can be distressing and time-consuming. Corneal impression membranes (CIM) have recently been introduced to another National Health Service (NHS) eye unit (St Paul's Eye Unit, Liverpool) as they detect more micro-organisms and are more patient-friendly than corneal scrape. The aim of this study is to compare CIM with reference to current standard practice of corneal scrape. If CIM have greater sensitivity and fewer adverse events than scrape then the investigators will consider using CIM instead of scrape in routine clinical care. The investigators will also collect additional CIM to help develop new microbiological tests being developed at the University of Edinburgh, which if successful could be applied to CIM at the bedside to further improve the speed of diagnosis in the future. Development of the new microbiological tests is facilitated by having samples of germs from eye infections.
Study design: cross-sectional study comparing diagnostic techniques Participants: recruited from the Acute referral clinic at the Princess Alexandra Eye Pavilion, or emergency on-call ophthalmology service What is involved: subjects with microbial keratitis will have standard investigations to identify the germ causing the infection. In addition the investigators will capture germs using CIM, and will compare CIM with the standard test to see which is better.
Funding: departmental funding
详细描述
Microbial keratitis is a common serious eye disease in Edinburgh. Prompt treatment with antibiotics can prevent sight loss, and identification of the micro-organism and its sensitivities are key to appropriate management. It is standard practice to collect multiple samples from the cornea using a needle or blade and plate material from an ulcer onto culture media. However this can be distressing to the patient, and the procedure can be especially difficult in those who are not co-operative or where there is a risk of corneal perforation. Corneal scrapes are also time consuming to prepare and perform. Corneal impression membranes (CIM) have recently been introduced to clinical practice in St Paul's Eye Unit in Liverpool, after a study found significantly higher isolation of micro-organisms from CIM compared to corneal scrape (40.8% vs 26.9% in n=130 eyes). However, CIM are not currently used in clinical practice in Scotland, and the results from Liverpool have not yet been replicated in a second study.
What questions does the study aim to answer?
- Is CIM better at capturing the germ causing corneal infection than corneal scrape in Edinburgh?
- Is CIM acceptable in terms of side effects, compared to corneal scrape?
- Can new diagnostic techniques be used on CIM to detect micro-organisms?
What new information will the research provide? Whether or not CIM are clinically useful in Edinburgh. It is possible that this study will find a higher frequency of contaminants with CIM, and the investigators will record the specific organism as well as the frequency for analysis. The project will also determine if new diagnostic techniques being developed in the University of Edinburgh can be used on CIM from patients.
This is a cross-sectional study aiming to compare the diagnostic accuracy of corneal impression membrane (CIM) against a clinical reference standard of corneal scrape.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18 years old or older
- •Appearances typical of a new bacterial, fungal or acanthamoeba infection of the cornea, in one or both eyes
- •Able to give informed consent
排除标准
- •Patients who don't give consent
- •Patients who would not normally have a corneal scrape as part of routine care. This includes patients with viral rather than bacterial corneal infection, such as herpetic keratitis.
- •Patients with corneal perforation or descemetocele
结局指标
主要结局
Sensitivity
时间窗: through study completion, an average of 1 year
Sensitivity of corneal membrane to detect microbes, compared to corneal scrape
次要结局
- Adverse events(through study completion, an average of 1 year)