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

June 27, 2022 updated by: Miklos Schneider MD, PhD, Semmelweis University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis University, Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

White Caucasian

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy patients
Healthy volunteers without retinal disease, glaucoma, previous ocular surgery, laser photocoagulation, or optical media opacities that would disturb imaging.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, 1 year
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.
Through study completion, 1 year
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.
Through study completion, 1 year
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.
Through study completion, 1 year
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.
Through study completion, 1 year
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.
Through study completion, 1 year
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.
Through study completion, 1 year
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.
Through study completion, 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Principal Investigator: Miklós Schneider, MD, PhD, Semmelweis University, Department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • VESDEN-OCTA-1253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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