To compare, the perifoveal microvascular changes (non-perfusion areas) in the deep capillary plexus layer between Behçet patients with and without ocular involvement and control subjects, using OCT-A.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Non-perfusion areas in the deep capillary plexus (DCP).
Secondary outcome
Other non-perfusion areas, visual acuity, retinal and choroidal thickness,
macular edema and (subjectively) observed microvascular abnormalities.
Background summary
Behçet disease (BD) is a systemic vasculitis, with ocular involvement in up to
70% of the patients. This is most often expressed in bilateral panuveitis with
retinal vasculitis. The new non-invasive image modality, optical coherence
tomography angiography (OCT-A), was deployed in patients with Behçet Uveitis
(BU) in previous studies, showing deviances in non-perfusion areas in the
retinal capillary plexus and foveal avascular zone (FAZ) compared to control
subjects. It is unknown whether OCT-A images of Behçet patients without ocular
involvement show similar subclinical vascular abnormalities.
Study objective
To compare, the perifoveal microvascular changes (non-perfusion areas) in the
deep capillary plexus layer between Behçet patients with and without ocular
involvement and control subjects, using OCT-A.
Study design
Case-control study.
Study burden and risks
The study measurements involve best corrected visual acuity (BCVA), fundus
photography, OCT macular volume scans and OCT-A plots. All non-uveitis subjects
will also undergo a full ophthalmic evaluation. The burden is considered low,
the diagnostic tests are non-invasive and not time-consuming. The total
duration is estimated to be 3 hours. There will be an effect due to the
mydriatic drop, used for pupil dilation, which will last for 2-4 hours after
the examinations.
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Schiedamse Vest 180
Rotterdam 3011 BH
NL
Listed location countries
Age
Inclusion criteria
All participants:
Signed informed consent
At least 18 years old;Behcet & Uveitis patients:
Diagnosed with Behçet disease, at least 1 year ago
Diagnosed with Behçet uveitis at least 6 months ago;Behcet patients without Uveitis:
Diagnosed with Behçet disease, at least 1 years ago
Not diagnosed with Behçet uveitis;Healthy volunteers:
No known chorioretinal pathologies or uveitis
Exclusion criteria
Ocular surgery within the last 3 months, except for uncomplicated cataract surgery
Participation in another ophthalmic trial using an investigational drug within the last 12 weeks
Other active ocular diseases which irreversibly compromise visual acuity or good visualization of the study eye
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 | NL64694.078.18 |