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Clinical Trials/NCT02811536
NCT02811536
Completed
Not Applicable

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

Insel Gruppe AG, University Hospital Bern1 site in 1 country440 target enrollmentFebruary 13, 2017
ConditionsRetinal Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Retinal Disease
Sponsor
Insel Gruppe AG, University Hospital Bern
Enrollment
440
Locations
1
Primary Endpoint
Evaluation of the sensitivity and specificity of OCTA
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 13, 2017
End Date
November 25, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Evaluation of the sensitivity and specificity of OCTA

Time Frame: 2 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 Outcomes

  • Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA(2 years)
  • OCTA and Fundus color photographs(2 years)
  • Subgroup analysis(2 years)

Study Sites (1)

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