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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02811536
Enrollment
440
Registered
2016-06-23
Start date
2017-02-13
Completion date
2022-11-25
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Disease

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.

Interventions

DEVICEoptical coherence tomography angiography

Imaging with optical coherence tomography angiography

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the sensitivity and specificity of OCTA2 yearsThe 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

MeasureTime frameDescription
Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA2 yearsThe 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 yearsEvaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA
Subgroup analysis2 yearsSubgroup 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026