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
Higher prevalence of certain virussen/bacteria in the study group compared with
controls.
Differential expression of proteins involved in inflammation and tissue
(re-)generation in the study group compared with controls.
Secondary outcome
Differential expression of proteins involved in inflammation and tissue
(re-)generation within the study subgroups dacryoadenitis, myositis, sclerosing
and diffuse. Quality of life of patients suffering from idiopathic orbital
inflammation.
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
Observational study without invasive measurements
Study burden and risks
Standard medical care of a patient with an orbital pseudotumor is an outpatient
clinic visit consisting of an extensive history, full ophthalmologic
examination, blood tests, picture, CT/MRI, systemic screening by an internist.
This outpatient visit (in the vast majority of patients) is followed by a
hospital admission to take an orbital biopsy (this may take 3 hours to 3 days
depending on localisation of the pseudotumor). Only the part of the biopsy
tissue that is not used for histology, is used for this study.
After consent for study participation, extra for this study a quality of life
form is filled out twice. There will be one additional blood withdrawal for max
two 5 ml-vials of blood.
There are no extra risks involved for the subjects in study participation.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
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 who have an orbital biopsy planned for a presumed orbital pseudotumor as part of regular medical care.
Exclusion criteria
Exclusion of identifiable local causes such as neoplasia and primary infection. No informed consent. No biopsy planned.
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 | NL17219.041.07 |