Of each new device it is unknown what the validity is and what the differences (advantages and disadvantages) are compared to the daily used devices.The aim of this study is to answer the question: What is the validity and are the objective benefits…
ID
Source
Brief title
Condition
- Ocular structural change, deposit and degeneration NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
OCT: direct comparison of B-scans, with respect to the quality and the
diagnostic value of the images.
Secondary outcome
practicallity of the examination, examination time and comfort of the pastient
during the examination, additional (diagnostic) value of OCTscans of the
anterior chamber angle and the peripheral retina.
Background summary
Optical Coherence Tomography (OCT) is an imaging technique used in
ophthalmology. The images are detailed cross sectional images, for example, of
the cornea, retina or optic nerve head. The obtained measurements give
important information about the morphology of a lesion in the eye. This
information is used for diagnosis and follow-up.
Recently a new device has been developed. A slit-lamp, used by the
ophthalmologist for basic examination, combined with an OCT (slit-lamp
integrated OCT; SLSCAN). This new device can be of use in the clinic. The
ophthalmologist can examine the abnormality in the eye with the slit-lamp, and
simultaneously make an OCT-scan of the exact location of the lesion. An other
advantage is that all examinations can be made with one device.
Study objective
Of each new device it is unknown what the validity is and what the differences
(advantages and disadvantages) are compared to the daily used devices.
The aim of this study is to answer the question:
What is the validity and are the objective benefits/limitations of the SI-OCT
Topcon compared to conventional examinations (slit-lamp biomicroscopy plus OCT
separately) in patients with anterior segment pathology, retinopathy or
glaucoma
Study design
Prospective observational study; Evaluation of a diagnostic procedure.
Study burden and risks
The burden to the patient is minimal and consist mainly of the time of
examination with the SI-OCT. Following the standard OCT procedure, the SLSCAN
will be performed. The SI-OCT procedure carries no known additional risks.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients: with an indication for OCT examination and / or examination with a 3-mirror contactlens;
Volunteers: no ocular pathology
All subjects:18 years of age or older; Willing and able to sign the informed consent, after reading the patient information form
Exclusion criteria
Cognitive disorders;
Media opacities, like cataract, causing unreliable images with the OCT
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 | NL26994.018.09 |