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Completed

NCT Number: NCT03590899

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

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.

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Key information

Conditions

Healthy

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University, Department of Ophthalmology

Budapest, 1085, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy patients without eye disease

Exclusion criteria

  • incapacity
  • any history or clinical evidence of retinal disease or glaucoma
  • previous ocular surgery or laser photocoagulation
  • optical media opacities that would disturb imaging

Treatment and study plan

Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)

Device

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.

Primary outcomes

  1. Vessel density (VD) measured by Mexican Hat filtering technique

    Time frame: Through study completion, 1 year

    Following standard OCTA imaging with Zeiss Cirrus Angioplex, images are transferred to ImageJ and proportion of the vessels and the total image area (white pixels2/total number of pixels2) is calculated using Mexican Hat filtering technique.

  2. Skeleton density (SD) measured by Mexican Hat filtering technique

    Time frame: Through study completion, 1 year

    Following standard OCTA imaging with Zeiss Cirrus Angioplex, images are transferred to ImageJ and length of blood vessels (white skeletonized pixels/total number of pixels2) is calculated using Mexican Hat filtering technique.

  3. Vessel diameter index (VDI) measured by Mexican Hat filtering technique

    Time frame: Through study completion, 1 year

    Represents the average vessel caliber (two dimensional white pixels in the binarized image/one dimensional white pixels in the skeletonized image or VD/SD) using Mexican Hat filtering technique.

  4. Vessel density (VD) measured by Shanbag tresholding technique

    Time frame: Through study completion, 1 year

    Following standard OCTA imaging with Zeiss Cirrus Angioplex, images are transferred to ImageJ and proportion of the vessels and the total image area (white pixels2/total number of pixels2) is calculated using Shanbag tresholding technique.

  5. Skeleton density (SD) measured by Shanbag tresholding technique

    Time frame: Through study completion, 1 year

    Following standard OCTA imaging with Zeiss Cirrus Angioplex, images are transferred to ImageJ and length of blood vessels (white skeletonized pixels/total number of pixels2) is calculated using Shanbag tresholding technique.

  6. Vessel diameter index (VDI) measured by Shanbag tresholding technique

    Time frame: Through study completion, 1 year

    Represents the average vessel caliber (two dimensional white pixels in the binarized image/one dimensional white pixels in the skeletonized image or VD/SD) using Shanbag tresholding technique.

  7. Vessel density (VD) measured by Angioplex Metrix

    Time frame: Through study completion, 1 year

    Following standard OCTA imaging with Zeiss Cirrus Angioplex measurement is done by built-in non-disclosed VD algorithm owned by Zeiss.

  8. Skeleton density (SD) measured by Angioplex Metrix

    Time frame: Through study completion, 1 year

    Following standard OCTA imaging with Zeiss Cirrus Angioplex measurement done by built-in non-disclosed SD algorithm owned by Zeiss.

Secondary outcomes

  1. Comparison of results obtained by the three quantification techniques

    Time frame: Through study completion, 1 year

    Comparison of VD and SD (see above) obtained by Mexican Hat filtering technique, Shanbag tresholding technique and built-in Zeiss proprietary algorithm.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Jul 18, 2018
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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