The Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between the Sensibility of the Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

Conditions
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Herpes Simplex Keratitis

Intervention / Treatment
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* Procedure: Corneal sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer) Exclusion Criteria: Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flocked swab (Copan 519CS01)<br>Sampling of the cornea by the flocked swab | Procedure: Corneal sampling<br>* Slit lamp corneal sampling with a Swab<br>|
| Experimental: Traditionnal fiber swab (Copan 164KS01)<br>Sampling of the cornea by the traditional finer swab | Procedure: Corneal sampling<br>* Slit lamp corneal sampling with a Swab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of the culture | 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. | 1 month after the initial visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time before positivity of the culture | If the culture is positive for Herpes simplex virus, what is the time lapse(in day) before the culture became positive. The research team will collect the data 1 month in average after the initial visit by examining the microbiologic data of the laboratory. | 1 month after the initial visit | 
| Viral load concentration | Quantitative polymerase chain reaction (PCR) will be on a part of the sampling 1 month after the initial visit. The result will be the concentration of virus in number/ml detected in the sampling | 1 month after the initial visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flocked swab, Traditional fiber swab, Herpes simplex epithelial keratitis, Quantitative PCR