The Efficacy of Two Potential Diagnostic Assays for Herpes Simplex Keratitis (HSK)
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Purpose
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.
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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. |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2006 |
| Study Completion Date: | November 2012 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
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
Contacts and Locations| United Kingdom | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00357812 History of Changes |
| Other Study ID Numbers: | 04/NIR03/20 |
| Study First Received: | July 26, 2006 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by University of Ulster:
|
Herpes Simplex Virus Type 1 Herpes Simplex Keratitis Cornea Dendretic Ulcer In vivo Confocal Microscopy |
Nested Multi-plex PCR Monoclonal Antibody Glycoprotein D Glycoprotein C |
Additional relevant MeSH terms:
|
Herpes Simplex Keratitis, Herpetic Keratitis Herpesviridae Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases |
Eye Infections, Viral Corneal Diseases Eye Diseases Eye Infections Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013