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

Phase 4
Terminated
Conditions
Herpes Simplex Keratitis
Interventions
Procedure: Corneal sampling
Registration Number
NCT02045082
Lead Sponsor
CHU de Quebec-Universite Laval
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
146
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Flocked swab (Copan 519CS01)Corneal samplingSampling of the cornea by the flocked swab
Traditionnal fiber swab (Copan 164KS01)Corneal samplingSampling of the cornea by the traditional finer swab
Primary Outcome Measures
NameTimeMethod
Result of the culture1 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.

Secondary Outcome Measures
NameTimeMethod
Viral load concentration1 month after the initial visit

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

Time before positivity of the culture1 month after the initial visit

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.

Trial Locations

Locations (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

🇨🇦

Québec, Quebec, Canada

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