UveitisNCT00676624
Infectious Causes of Uveitis
An observational study of Uveitis, run by Statens Serum Institut at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient at a referal hospital eye clinic with uveitis were vitrectomy will be performed for diagnostic reasons
Who may be able to join
- Patient at Glostrup Hospital refferal eye clinic with uveitis were vitrectomy will be performed for diagnostic reasons
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infectious Causes of Uveitis, With Special Focus on Infection With Leptospira
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.
Read more
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.
Read the 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.
- Conditions
- Uveitis
- Keywords
- uveitis, vitrectomy, infection, severe
- Medical subject headings
- Uveitis, Infections, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and distribution of intraocular infections in the study group
Measured: September 2010
Secondary outcomes (1)
The value of non-specific molecular diagnostic methods for detection of bacteria in the study group
Measured: September 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, University of Copenhagen
- Responsible party
- Principal investigator, Steen Villumsen, Statens Serum Institut
- Investigators
- Steen Villumsen, MD PhD stud, Principal investigator, Statens Serum InstitutMorten la Cour, MD DMSc, Study chair, Glostrup University Hospital, CopenhagenKaren A Krogfelt, Prof. PhD, Study chair, Statens Serum InstitutHelle J Fuchs, MD, Study chair, Glostrup University Hospital, CopenhagenJan U Prause, MD Prof DMSC, Study chair, University of CopenhagenHenrik V Nielsen, PhD, Study chair, Statens Serum InstitutLars P Nielsen, MD, Study chair, Statens Serum InstitutVibeke Thomsen, Cand Scient, Study chair, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676624
- Sponsor's protocol ID
- H-B-2007-097
- Status last verified
- May 2014
- First submitted
- 8 May 2008
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11470987
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infectious Causes of Uveitis, With Special Focus on Infection With Leptospira
- ClinicalTrials.gov ID
- NCT00676624
- Acronym / sponsor ID
- H-B-2007-097
- Conditions
- Uveitis
- Keywords
- uveitis, vitrectomy, infection, severe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, University of Copenhagen
- Study start
- Apr 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient at a referal hospital eye clinic with uveitis were vitrectomy will be performed for diagnostic reasons
Key inclusion criteria (1 listed)
- Patient at Glostrup Hospital refferal eye clinic with uveitis were vitrectomy will be performed for diagnostic reasons
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and distribution of intraocular infections in the study group
Time frame: September 2010
1 secondary outcome
The value of non-specific molecular diagnostic methods for detection of bacteria in the study group
Time frame: September 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Background: PubMed 11470987Bodaghi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen Villumsen, MD PhD stud principal investigator
Statens Serum Institut
Morten la Cour, MD DMSc study chair
Glostrup University Hospital, Copenhagen
Karen A Krogfelt, Prof. PhD study chair
Statens Serum Institut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Statens Serum Institut at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and distribution of intraocular infections in the study group (time frame: September 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014; AzTrials last refreshed its copy on 1 Nov 2026.