Infectious Causes of Uveitis

This study has been completed.
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
University of Copenhagen
Information provided by (Responsible Party):
Steen Villumsen, Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT00676624
First received: May 8, 2008
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

Uveitis is an inflammatory disease of one or both eyes. Uveitis will in severe cases lead to permanent loss of vision/blindness on the affected eye. Uveitis can be caused by autoimmune disease, infections and rarely trauma, but 50 % of the cases remain of unknown origin. Intraocular infections are from previous studies, known to be responsible for approximately 40 % of the cases of severe forms of uveitis. Most infectious causes of uveitis have the potential to be treated with antibiotic.

Most infectious causes of uveitis are under normal condition only possible to detect by using very specific detection methods. Further more it is often necessary to study a sample from with-in the eye (vitrectomy to get a proper diagnosis. The knowledge about witch kind of infections that causes uveitis, are therefore limited to the kind of infections that are tested for.

Our hypothesis are that infections are a frequent cause of severe uveitis in Denmark, and that by using a broad diagnostic approach it is possible to identify new or less recognized infections agents that are associated with uveitis. By this study we want to describe the prevalence and distribution of infections among patients with severe uveitis. In this study are we only including patients with a severe form of uveitis from a referral-hospital setting, where vitrectomy is done for a diagnostic purpose.

The patients will undergo a standard diagnostic examination including the most common infectious causes of uveitis. Beside this we will look for a broad range of infection, which has previously been described in the litera-ture to cause uveitis, but are not normally tested for. Further more, we will use broad ranged molecular diagnostic methods to look for new previously unknown bacterial causes of uveitis. Such study has not previously been done previously in Denmark. As control group are included patients that undergo vitrectomy for due either one of the two diseases "epiretinal fibrosis or "macula hole". All patients and controls will be interview using a standardized questionnaire about risk factors for acquiring these infections.


Condition
Uveitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Infectious Causes of Uveitis, With Special Focus on Infection With Leptospira

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • Prevalence and distribution of intraocular infections in the study group [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The value of non-specific molecular diagnostic methods for detection of bacteria in the study group [ Time Frame: September 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Corpus vitreum (vitreus body) Aqua from the anterior champer Whole blood in dry container Whole blood in container containing EDTA Whole blood in QuantiFERON test KIT for tuberculosis Urine


Estimated Enrollment: 100
Study Start Date: April 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Uveitis
Patients suffering from uveitis, who have vitrectomy performed for diagnostic purpose
Control group
Patients suffering from either "Epiretinal fibrosis" og "Macula hole" who have vitrectomy performed for curative reasons

Detailed Description:

All patients included eye examination that includes split-lamp examination with semi-quantification evaluation of the inflammation, fundoscopy incl. picture, and angiography.

Hemoglobin (Hb), Erythrocyte-volume fraction (EVF), Middle cell volume (MCV), middelcell hemoglobin concentration (MCHC), Trombocyte

  • Alanin-aminotransferase (ALAT), S-albumin, S-bilirubin (total), Protrombin complex, INR.
  • Na, K, creatinin,
  • CRP, Leukocyte and differential count
  • ACE (Angiotensin Converting Enzyme)
  • S-Ca2+

X-ray of thorax

The biopsies taken from the patient are in the routine program are patients tested for intraocular infections with Herpes Simplex Virus, Cytomegalovirus, Varicella Zoster virus, Epstein-Barr virus and toxoplasma with PCR and serology on serum. Test for others infections like Candida spp. and Toxocare are done if clini-cally indicated. Other test includes cytopathological test of the corpus vitreum for cancer cells and serological test for Syphilis.

Beside the above mentioned test will we in this study test for:

Infections with Leptospira, Bartonella, Brucella, Mycobacterium tuberculosis, Leptospira, Toxocare, Borrelia, HIV.

We will use unspecific molecular test for Bacteria under a special setup to avoid DNA contamination. Culture of Leptospira will be done on urine samples.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient at a referal hospital eye clinic with uveitis were vitrectomy will be performed for diagnostic reasons

Criteria

Inclusion Criteria:

  • Patient at Glostrup Hospital refferal eye clinic with uveitis were vitrectomy will be performed for diagnostic reasons

Exclusion Criteria:

  • patients where eye surgery has been performed on the affected eye, within 30 days before the current vitrectomy
  • Patients with known lymphoma
  • Patient with clinical suspicion of intra-ocular cancer disease
  • Pregnant and lactating women
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676624

Locations
Denmark
Glostrup Hospital
Glostrup, Denmark, 2600
Sponsors and Collaborators
Statens Serum Institut
Glostrup University Hospital, Copenhagen
University of Copenhagen
Investigators
Principal Investigator: Steen Villumsen, MD PhD stud Statens Serum Institut
Study Chair: Morten la Cour, MD DMSc Glostrup Hospital
Study Chair: Karen A Krogfelt, Prof. PhD Statens Serum Institut
Study Chair: Helle J Fuchs, MD Glostrup Hospital
Study Chair: Jan U Prause, MD Prof DMSC University of Copenhagen
Study Chair: Henrik V Nielsen, PhD Statens Serum Institut
Study Chair: Lars P Nielsen, MD Statens Serum Institut
Study Chair: Vibeke Thomsen, Cand Scient Statens Serum Institut
Study Chair: Anne-Mette Lebech, MD, DMSc Hvidovre University Hospital
Study Chair: Jorgen S Jensen, MD DMSc Statens Serum Institut
  More Information

Publications:
Responsible Party: Steen Villumsen, MD, PhD, Statens Serum Institut
ClinicalTrials.gov Identifier: NCT00676624     History of Changes
Other Study ID Numbers: H-B-2007-097
Study First Received: May 8, 2008
Last Updated: May 14, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Statens Serum Institut:
uveitis
vitrectomy
infection
severe

Additional relevant MeSH terms:
Communicable Diseases
Infection
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on July 28, 2014