A comparison of the PR-OCT and conventional ways of examination of patients, being slitlamp biomicrsocopy combined with stand alone SD-OCT, and fluorescein / ICG angiography, or glaucoma screening.
ID
Source
Brief title
Condition
- Ocular haemorrhages and vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome parameter(s) PR-OCT
Added value of PR-OCT compared to conventional procedure(s)
Sensitivity / specificity detection of pathology compared to conventional
procedure(s)
Secondary outcome
Outcome parameters PR-OCT
• Duration of procedure
• Quality of images
• Patients* experience of comfort degree
Background summary
In ophthalmology the conventional spectral domain optical coherence tomography
(SD-OCT) has become indispensable to examine the retina and optic nerve head.
Recently a prototype was constructed of an integrated Phase Resolved-optical
coherence tomograph (PR-OCT). This device is expected to improve the
visualisation of retinal pathology, adding detailed images of the retinal and
choroidal vasculature, and of retardation differences in parts of the retina,
like the RPE and the RNFL, and subretinal fibrosis, as can be seen in wet Age
related Macular Degeneration.
Study objective
A comparison of the PR-OCT and conventional ways of examination of patients,
being slitlamp biomicrsocopy combined with stand alone SD-OCT, and fluorescein
/ ICG angiography, or glaucoma screening.
Study design
Prospective observational (pilot) study; Evaluation of a diagnostic procedure.
Study burden and risks
Because the PR-OCT is a prototype, there is not yet a CE-marking. Though, the
PR-OCT meets all the safety requirements. The light intensity during the
procedure is comparable with the conventional SD-OCT and slit-lamp
biomicroscopy. The device also meets the electrical safety requirements.
Patients already scheduled for angiography will not experience additonal
discomfort or risks.
Patients without this indication, and healthy volunteers, will recieve mydratic
eye drops, these drops can be, very temporarely, mildly irritating, and will
lead to blurring of vision for a few hours.
De Boelelaan 1117
Amsterdam 1081HZ
NL
De Boelelaan 1117
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects, without any known ocular diseae / pathology, or general disesase known to influence retinal vessels and / or the neuroretina.
Patients with an indication for FA and / or ICG angiography, in particular with wet Age related Macular Degeneration, Diabetic Retinopathy, Retinal vascular occlusions, Central Serous Chorioretinopathy.
Patients with ocular hypertension or glaucoma.
Age 18 years or older.
Willing and able o sign informed consent
Exclusion criteria
Ocular spherical equivalent > +5D or < -8 D
Ocular media opacities preventing good quality images
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 | NL51324.029.15 |