This study aims to gain insights in the pathogenesis of idiopathic orbital inflammation, with ultimately a directer and more effective therapy.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prospective case-control study: infectious study: presence/absence of twenty
virusses and micro-organisms; genomic study: differential expression of
twenty-five proteins involved in inflammation and tissue (re)-generation.
Secondary outcome
none
Background summary
Idiopathic orbital inflammation is a relatively common disease of the orbit.
About half of patients have incomplete responses to current steroid therapy and
recurrences are common. Therefore, a better therapy is sought for. The
pathognesis of idiopathic orbital inflammation is still unrevealed.
Study objective
This study aims to gain insights in the pathogenesis of idiopathic orbital
inflammation, with ultimately a directer and more effective therapy.
Study design
Three questions are considered:
1. Is there an infectious trigger dysregulating the immune system in idiopathic
orbital inflammation?
2. What genetic predisposition and environmental variables are of importance in
the pathogenesis of idiopathic orbital inflammation?
3. What pathologic processes are identified to be of importance on a genomic
scale?
The study is subdivided in a retrospective case-control study to answer
question two and a prospective study with tissue biopsies to answer questions
one and three. The case-control study is not part of this application.
Study burden and risks
Currently in the Netherlands, biopsies are performed in the vast majority of
patients in which a diagnosis of idiopathic orbital inflammation is considered.
For these patients there is only a small burden of extra administration (10-20
minutes). In about 20% of cases one is more prone to take a biopsy for this
study. For those patients the burden is a hospital admittance and an operation
under general anesthesia. They profit from a histologic diagnosis and a
directer treatment. Vision and motility risks are avoided.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Adult patients presenting to the ophthalmology clinic with signs of (sub) acute infiltration and inflammation of intraorbital structures together with symptoms of eyelidedema, conjunctival injection, chemosis, pain and/or motilitydisturbances.
Exclusion criteria
Exclusion of identifiable local causes such as neoplasia, primary infection and systemic diseases like Wegener and Graves'.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14931.041.07 |