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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590899
Recruitment Status : Active, not recruiting
First Posted : July 18, 2018
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Miklos Schneider MD, PhD, Semmelweis University

Brief 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.

Condition or disease Intervention/treatment
Healthy Device: Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)

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.

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Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Group/Cohort Intervention/treatment
Healthy patients 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
White Caucasian
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590899


Locations
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Hungary
Semmelweis University, Department of Ophthalmology
Budapest, Hungary, 1085
Sponsors and Collaborators
Semmelweis University
Investigators
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Principal Investigator: Miklós Schneider, MD, PhD Semmelweis University, Department of Ophthalmology

Publications:

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Responsible Party: Miklos Schneider MD, PhD, Principal Investigator, Assistant Professor of Ophthalmology, Head of General Outpatient Unit, Semmelweis University
ClinicalTrials.gov Identifier: NCT03590899    
Other Study ID Numbers: VESDEN-OCTA-1253
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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