We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00357812
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : January 15, 2013
Information provided by:

Study Description
Brief Summary:

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 Design

Study Type : Observational
Estimated Enrollment : 50 participants
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.
Study Start Date : September 2006
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

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

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
Principal Investigator: Tara Moore, PhD Department of Biomedical Sciences, University of Ulster
More Information

ClinicalTrials.gov Identifier: NCT00357812     History of Changes
Other Study ID Numbers: 04/NIR03/20
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: November 2012

Keywords provided by University of Ulster:
Herpes Simplex Virus Type 1
Herpes Simplex Keratitis
Dendretic Ulcer
In vivo Confocal Microscopy
Nested Multi-plex PCR
Monoclonal Antibody
Glycoprotein D
Glycoprotein C

Additional relevant MeSH terms:
Herpes Simplex
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