The Efficacy of Two Potential Diagnostic Assays for Herpes Simplex Keratitis (HSK)

This study has been completed.
Sponsor:
Collaborators:
Bedford Hospital NHS Trust
Midlands Eye Clinic
Royal Victoria Hospital, Belfast
Information provided by:
University of Ulster
ClinicalTrials.gov Identifier:
NCT00357812
First received: July 26, 2006
Last updated: January 14, 2013
Last verified: November 2012
  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.


Condition Phase
Herpes Simplex Keratitis
Phase 1

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.

Resource links provided by NLM:


Further study details as provided by University of Ulster:

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
Study Population

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

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00357812

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
Sponsors and Collaborators
University of Ulster
Bedford Hospital NHS Trust
Midlands Eye Clinic
Royal Victoria Hospital, Belfast
Investigators
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
Keratitis, Herpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Corneal Diseases
Eye Diseases
Eye Infections, Viral
Eye Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014