The Efficacy of Two Potential Diagnostic Assays for Herpes Simplex Keratitis (HSK)
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|ClinicalTrials.gov Identifier: NCT00357812|
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : January 15, 2013
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.
|Condition or disease||Phase|
|Herpes Simplex Keratitis||Phase 1|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||A Study to Compare the Efficacy of Two Potential Diagnostic Assays: a Fluorescein Conjugated Monoclonal Antibody in Vivo Assay and Nested Real Time PCR Assay to Rapidly and Accurately Diagnose Herpes Simplex Keratitis.|
|Study Start Date :||September 2006|
|Study Completion Date :||November 2012|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357812
|Birmingham and Midlands Eye Clinic|
|Birmingham, Midlands, United Kingdom, B18 79H|
|Bedford Hospital Ophthalmology Department and Acute Eye Clinic|
|Bedford, United Kingdom|
|Royal Victoria Hospital|
|Belfast, United Kingdom|
|Principal Investigator:||Tara Moore, PhD||Department of Biomedical Sciences, University of Ulster|