Comparison Between the Sensibility of the Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Result of the culture
研究概览
简要总结
The purpose of this study is to compare a corneal sampling realized by a flocked swab (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab 164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes simplex epithelial keratitis will be the primary objective of this study.
详细描述
In our center, the flocked swabs became an important tool in the corneal sampling for viral keratitis, replacing rightly or wrongly the former traditional fibers swab. No research was specifically designed to study the corneal taking with these swabs. Nevertheless, numerous reasons would motivate it, because of the peculiarities in ophthalmology: the corneal sampling has to be made with the slit lamp rather than in a macroscopic manner; the corneal lesion are often millimetre-length and confined; the histology of the cornea is unique and compares only imperfectly with other structures of the human body like the nasal mucosa. In these circumstances, the properties of the stalk (rigidity, length) and of its extremity (roughness, textures, absorbance) can influence the quality of the sampling and the final result of the culture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer)
排除标准
- •Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea
结局指标
主要结局
Result of the culture
时间窗: 1 month after the initial visit
The result can be Positive or negative for Herpes simplex virus (HSV). Even if the result will be available in less than 1 week by the clinician after the culture, the research team will collect the data 1 month in average after the initial visit.
次要结局
- Viral load concentration(1 month after the initial visit)
- Time before positivity of the culture(1 month after the initial visit)
