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

Completed

• Conditions: Retinal Disease

• 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.

Study Timeline

• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-23
• Study Start: 2017-02-13
• Status Verified: 2022-11
• Primary Completion: 2022-11-25
• Study Completion: 2022-11-25
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-29

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

Primary Outcome Measures

Name	Time	Method
Evaluation of the sensitivity and specificity of OCTA	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 Outcome Measures

Name	Time	Method
Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA	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.
OCTA and Fundus color photographs	2 years	Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA
Subgroup analysis	2 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