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

NCT00357812 | Completed

• 1 other identifier: 04/NIR03/20
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Herpes Simplex Keratitis

Keywords

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Immunosuppressed patients including patients treated with systemic steroids will be excluded

Sponsors & Collaborators

• University of Ulster: lead
• Bedford Hospital NHS Trust: collaborator
• Midlands Eye Clinic: collaborator
• Royal Victoria Hospital, Belfast: collaborator

Study Sites (3)

Birmingham and Midlands Eye Clinic

Birmingham, Midlands, B18 79H, United Kingdom

Location

Bedford Hospital Ophthalmology Department and Acute Eye Clinic

Bedford, United Kingdom

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Keratitis, Herpetic; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Eye Diseases

Study Officials

• Tara Moore, PhD

  Department of Biomedical Sciences, University of Ulster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 28, 2006
• Study Start: September 1, 2006
• Study Completion: November 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2012-11

Locations

GB (3)