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

Sponsor

CHU de Quebec-Universite Laval (Other)

Overall Status

Terminated

CT.gov ID

NCT02045082

Collaborator

(none)

146

Enrollment

Location

Arms

Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex Keratitis	Procedure: Corneal sampling	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Flocked swab (Copan 519CS01)

Sampling of the cornea by the flocked swab

Procedure: Corneal sampling

Slit lamp corneal sampling with a Swab

Experimental: Traditionnal fiber swab (Copan 164KS01)

Sampling of the cornea by the traditional finer swab

Procedure: Corneal sampling

Slit lamp corneal sampling with a Swab

Outcome Measures

Primary Outcome Measures

Result of the culture [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.

Secondary Outcome Measures

Time before positivity of the culture [1 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.
Viral load concentration [1 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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