NCT00676624

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

May 8, 2008

Last Update Submit

May 14, 2014

Conditions

Keywords

uveitisvitrectomyinfectionsevere

Outcome Measures

Primary Outcomes (1)

  • Prevalence and distribution of intraocular infections in the study group

    September 2010

Secondary Outcomes (1)

  • The value of non-specific molecular diagnostic methods for detection of bacteria in the study group

    September 2010

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • Bodaghi B, Cassoux N, Wechsler B, Hannouche D, Fardeau C, Papo T, Huong DL, Piette JC, LeHoang P. Chronic severe uveitis: etiology and visual outcome in 927 patients from a single center. Medicine (Baltimore). 2001 Jul;80(4):263-70. doi: 10.1097/00005792-200107000-00005. No abstract available.

    PMID: 11470987BACKGROUND

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

MeSH Terms

Conditions

UveitisInfectionsLymphoma, Follicular

Condition Hierarchy (Ancestors)

Uveal DiseasesEye DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Steen Villumsen, MD PhD stud

    Statens Serum Institut

    PRINCIPAL INVESTIGATOR
  • Morten la Cour, MD DMSc

    Glostrup University Hospital, Copenhagen

    STUDY CHAIR
  • Karen A Krogfelt, Prof. PhD

    Statens Serum Institut

    STUDY CHAIR
  • Helle J Fuchs, MD

    Glostrup University Hospital, Copenhagen

    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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations