An observational study in Retinal Vascular and Normal Eyes, sponsored by Heidelberg Engineering GmbH. Terminated at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by Heidelberg Engineering GmbH · Observational
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS
The objectives of this study are to:
Heidelberg Engineering GmbH is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Pathology Population:
Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal vascular conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.
Normal Population:
In order to be included in the Normal population, subjects will have to meet all inclusion/exclusion criteria for both eyes. Subjects with a history of ocular surgical interventions will be excluded except for those with refractive and/or cataract surgery.
Subjects with Normal Eyes:
Subjects with Pathology:
Exclusion Criteria:
Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology
Device: OCT Angiography · Device: Color Fundus Photography · Device: Optical Coherence Tomography
Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular ophthalmic pathology
Device: OCT Angiography · Device: Color Fundus Photography · Device: Optical Coherence Tomography
OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
Also known as: OCTA
Non-contact white light photography
Also known as: CFP
Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.
Also known as: Structural OCT, OCT
OCTA image quality
Image quality grading results of study selected images
Time frame: day 1
Visualization of key anatomical vascular structures on OCTA
Grading of visibility of key anatomical vascular structures of study selected images
Time frame: day 1
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Heidelberg Engineering GmbH