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Research Question
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The aim of this study is to compare the safety, specificity, sensitivity and ease of
procedure of two potential diagnostic assays for HSV-1 detection in the cornea. Through the
use of this new diagnostic assay, correct and early intervention would not only reduce
corneal scarring from HSK, but it would also allow the initiation of appropriate treatment
for HSV mimicking keratitis.
HSV-1 infection of the eye can result in corneal scarring and blindness. Early diagnosis of
this condition and appropriate treatment is of utmost importance. Various ocular surface
conditions can mimic herpetic keratitis in their clinical presentation and can result in
diagnostic confusion. Inappropriate or delayed treatment of herpetic corneal disease results
in increased morbidity.
In the UK at present clinical presentation is the mainstay of diagnosis. Unfortunately these
cases often present to the most inexperienced clinical staff resulting in variability in
diagnostic acumen. This often results in a delay or inappropriate diagnosis of herpetic
keratitis. Laboratory techniques presently available to aid diagnosis are infrequently used
in clinical practice. There are various reasons for their lack of use. Historically viral
culture techniques were the mainstay of investigation but were slow, requiring weeks to
provide a result. PCR is now replacing culture techniques and is relatively quick, reliable
and sensitive. Many clinicians within the UK are still not fully informed of these advances
and are therefore not utilizing these techniques to supplement clinical diagnosis.
We propose to investigate the use of topically applied fluorescent antibody against active
replicating HSV-1 in a droplet form and real time PCR detection of the virus. If successful
this should increase the potential diagnostic capabilities of GPs and other less experienced
health care workers. Such tests should reduce variability in diagnosis and the dependency on
experienced ophthalmologists to diagnose the condition.
(from ClinicalTrials.gov)
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Ethics Approval
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Sorry, not currently available
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Study Design
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Time Perspective: Prospective
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Herpes Simplex Keratitis
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Participants Inclusion Criteria
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Inclusion Criteria:
Patients over the age of 16 years in which the cause of keratitis is difficult to diagnose
and in which HSK has to be excluded will be enrolled for this study
Exclusion Criteria:
Immunosuppressed patients including patients treated with systemic steroids will be
excluded
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Participants Exclusion Criteria
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Inclusion Criteria:
Patients over the age of 16 years in which the cause of keratitis is difficult to diagnose
and in which HSK has to be excluded will be enrolled for this study
Exclusion Criteria:
Immunosuppressed patients including patients treated with systemic steroids will be
excluded
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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50
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Completed
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England, Northern Ireland
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Location
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Birmingham, Bedford, Belfast
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Interventions
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Sorry, not currently available
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Primary Outcome Measures
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Sorry, not currently available
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Secondary Outcome Measures
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Sorry, not currently available
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Website
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Sorry, not currently available
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