NCT03590899

Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

Purpose of the study is to examine the vessel density of healthy adults' optical coherence tomography angiography images with two semi-manual methods and an automated quantification program.

Detailed description

Optical coherence tomography angiography (OCTA) is a software upgrade on conventional spectral-domain or swept-source optical coherence tomography devices that enables non-invasive, dye-free, three dimensional analysis of the retinal vessels. Vessel density is a very important parameter almost in all retinal disorders. In the recent past, automated quantification software was built into some OCTA devices which can automatically calculate the retinal vessel density as well. In this study two semi-manual techniques are used in order to analyze the vessel density of healthy subjects' OCTA images. Vessel density is also measured with a new automated quantification program, and results of the three methods are compared. OCT machines are approved in the EU and the US and are not experimental devices. The device used in this study is the commercially available Zeiss Cirrus HD OCT Angioplex 5000 that operates with spectral-domain technology.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)	Non-invasive, non-contact optical coherence tomography angiography scans of the retina are done per built-in device protocol using the Zeiss Cirrus HD OCT 5000 AngioPlex machine.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-11-20
• Completion: 2022-03-30
• First posted: 2018-07-18
• Last updated: 2022-06-30

Locations

1 site across 1 country: Hungary

Regulatory

• FDA-regulated device study