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

Retinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811536
• Other study ID #: OCTA Bern
• Status: Completed
• Start date: February 13, 2017
• Est. completion date: November 25, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: November 25, 2022
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Retinal Disease
• Retinal Diseases

Intervention

Device:
• optical coherence tomography angiography
Imaging with optical coherence tomography angiography

Locations

Country	Name	City	State
Switzerland	Inselspital Bern, Department of Ophthalmology	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	OCTA and Fundus color photographs	Evaluation whether pathological changes seen in OCT or color fundus photography correlate with changes seen in OCTA	2 years
Secondary	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