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Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)

Completed
Conditions
Retinal Disease
Interventions
Device: optical coherence tomography angiography
Registration Number
NCT02811536
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Brief Summary

Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
440
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Diabetic retinopathyoptical coherence tomography angiographyPatients with various degrees of diabetic retinopathy
Retinal detachmentoptical coherence tomography angiographyPatients with a history of retinal detachment
Arterial hypertensionoptical coherence tomography angiographyPatients with a history of arterial hypertension
Retinal vein occlusionoptical coherence tomography angiographyPatients with a history of retinal vein occlusion
Carotid artery occlusionoptical coherence tomography angiographyPatients with a history of carotid artery occlusion
Age related macular degenerationoptical coherence tomography angiographyPatients with a history of Age related macular degeneration
Macroaneurysmsoptical coherence tomography angiographyPatients with a history of retinal macroaneurysms
Central serous chorioretinopathyoptical coherence tomography angiographyPatients with a history of central serous chorioretinopathy
Primary Outcome Measures
NameTimeMethod
Evaluation of the sensitivity and specificity of OCTA2 years

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.

Secondary Outcome Measures
NameTimeMethod
Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA2 years

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.

OCTA and Fundus color photographs2 years

Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA

Subgroup analysis2 years

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.

Trial Locations

Locations (1)

Inselspital Bern, Department of Ophthalmology

🇨🇭

Bern, Switzerland

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