An observational study in Retinal Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases
Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.
740 studies on the registry are indexed under Eye Diseases; 118 are open to participants now.
This study's enrollment of 440 is above the median of 120 across 172 observational studies indexed under Eye Diseases.
Browse Eye Diseases studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
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Participants with a history of clinically diagnosed retinal diseases, including but not limited to age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, macular macroaneurysma, and diabetic macular edema and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included
Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older
Exclusion criteria:
Patients not willing or able to sign informed consent Patients younger than 18 years Patients with epilepsy Patients having had photodynamic therapy within the last 48 hours prior to imaging with OCTA
Patients with various degrees of diabetic retinopathy
Device: optical coherence tomography angiography
Patients with a history of retinal detachment
Device: optical coherence tomography angiography
Patients with a history of retinal vein occlusion
Device: optical coherence tomography angiography
Patients with a history of arterial hypertension
Device: optical coherence tomography angiography
Patients with a history of carotid artery occlusion
Device: optical coherence tomography angiography
Patients with a history of Age related macular degeneration
Device: optical coherence tomography angiography
Patients with a history of retinal macroaneurysms
Device: optical coherence tomography angiography
Patients with a history of central serous chorioretinopathy
Device: optical coherence tomography angiography
Imaging with optical coherence tomography angiography
Evaluation of the sensitivity and specificity of OCTA
The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose vascular abnormalities with OCTA compared to conventional imaging methods. The main parameter that will be assessed is area of nonperfusion of the retina. The incidence (binary) of nonperfusion areas will be assessed in OCTA and compared to conventional imaging methods such as fluorescein angiography.
Time frame: 2 years
Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA
The primary objective of this observational study is to evaluate the sensitivity and specificity to diagnose vascular abnormalities with OCTA compared to conventional imaging methods. The main parameter that will be assessed is area of nonperfusion of the retina. The incidence (binary) of nonperfusion areas will be assessed in OCTA and compared to conventional imaging methods such as fluorescein angiography.
Time frame: 2 years
OCTA and Fundus color photographs
Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA
Time frame: 2 years
Subgroup analysis
Subgroup analysis will be performed with patients suffering from diabetic retinopathy, artery occlusion, carotid stenosis, retinal detachment, vein occlusion, age related macular degeneration, retinal changes from arterial hypertension, retinal macroaneurysms and uveitis.
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern