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

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

Study Overview

• Status: Completed
• Conditions: Retinal Disease
• Intervention / Treatment: Device: optical coherence tomography angiography

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 Type: Observational
• Enrollment (Actual): 440

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern, Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic retinopathy; Patients with various degrees of diabetic retinopathy	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography
Retinal detachment; Patients with a history of retinal detachment	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography
Retinal vein occlusion; Patients with a history of retinal vein occlusion	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography
Arterial hypertension; Patients with a history of arterial hypertension	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography
Carotid artery occlusion; Patients with a history of carotid artery occlusion	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography
Age related macular degeneration; Patients with a history of Age related macular degeneration	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography
Macroaneurysms; Patients with a history of retinal macroaneurysms	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography
Central serous chorioretinopathy; Patients with a history of central serous chorioretinopathy	Device: optical coherence tomography angiography; Imaging with optical coherence tomography angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
OCTA and Fundus color photographs	Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA	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.	2 years

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Martin Zinkernagel, Prof.MD PhD, Inselspital, University Clinic for Ophthalmology

Publications and helpful links

General Publications

• Tian M, Tappeiner C, Zinkernagel MS, Huf W, Wolf S, Munk MR. Evaluation of vascular changes in intermediate uveitis and retinal vasculitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2019 Sep;103(9):1289-1295. doi: 10.1136/bjophthalmol-2018-313078. Epub 2018 Dec 11.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): November 25, 2022
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Retinal Diseases; Eye Diseases
• Other Study ID Numbers: OCTA Bern

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No