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

NCT03590899 | Completed FDA Device

• 1 other identifier: VESDEN-OCTA-1253
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• Vessel density (VD) measured by Mexican Hat filtering technique

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (1)

• Comparison of results obtained by the three quantification techniques

  Through study completion, 1 year

Study Arms (1)

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)

Interventions

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.

Healthy patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

White Caucasian

You may qualify if:

• healthy patients without eye disease

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Department of Ophthalmology

Budapest, 1085, Hungary

Location

Related Publications (20)

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• Coscas F, Sellam A, Glacet-Bernard A, Jung C, Goudot M, Miere A, Souied EH. Normative Data for Vascular Density in Superficial and Deep Capillary Plexuses of Healthy Adults Assessed by Optical Coherence Tomography Angiography. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT211-23. doi: 10.1167/iovs.15-18793.

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• Corvi F, Pellegrini M, Erba S, Cozzi M, Staurenghi G, Giani A. Reproducibility of Vessel Density, Fractal Dimension, and Foveal Avascular Zone Using 7 Different Optical Coherence Tomography Angiography Devices. Am J Ophthalmol. 2018 Feb;186:25-31. doi: 10.1016/j.ajo.2017.11.011. Epub 2017 Nov 21.

  PMID: 29169882 BACKGROUND

• Matsunaga D, Yi J, Puliafito CA, Kashani AH. OCT angiography in healthy human subjects. Ophthalmic Surg Lasers Imaging Retina. 2014 Nov-Dec;45(6):510-5. doi: 10.3928/23258160-20141118-04.

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• Tan PE, Balaratnasingam C, Xu J, Mammo Z, Han SX, Mackenzie P, Kirker AW, Albiani D, Merkur AB, Sarunic MV, Yu DY. Quantitative Comparison of Retinal Capillary Images Derived By Speckle Variance Optical Coherence Tomography With Histology. Invest Ophthalmol Vis Sci. 2015 Jun;56(6):3989-96. doi: 10.1167/iovs.14-15879.

  PMID: 26098464 BACKGROUND

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  PMID: 27296485 BACKGROUND

• Weinhaus RS, Burke JM, Delori FC, Snodderly DM. Comparison of fluorescein angiography with microvascular anatomy of macaque retinas. Exp Eye Res. 1995 Jul;61(1):1-16. doi: 10.1016/s0014-4835(95)80053-0.

  PMID: 7556462 BACKGROUND

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• Agrawal R, Xin W, Keane PA, Chhablani J, Agarwal A. Optical coherence tomography angiography: a non-invasive tool to image end-arterial system. Expert Rev Med Devices. 2016 Jun;13(6):519-21. doi: 10.1080/17434440.2016.1186540. Epub 2016 May 25. No abstract available.

  PMID: 27176114 BACKGROUND

• Munk MR, Giannakaki-Zimmermann H, Berger L, Huf W, Ebneter A, Wolf S, Zinkernagel MS. OCT-angiography: A qualitative and quantitative comparison of 4 OCT-A devices. PLoS One. 2017 May 10;12(5):e0177059. doi: 10.1371/journal.pone.0177059. eCollection 2017.

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• Zudaire E, Gambardella L, Kurcz C, Vermeren S. A computational tool for quantitative analysis of vascular networks. PLoS One. 2011;6(11):e27385. doi: 10.1371/journal.pone.0027385. Epub 2011 Nov 16.

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• Reif R, Qin J, An L, Zhi Z, Dziennis S, Wang R. Quantifying optical microangiography images obtained from a spectral domain optical coherence tomography system. Int J Biomed Imaging. 2012;2012:509783. doi: 10.1155/2012/509783. Epub 2012 Jun 26.

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• De Vitis LA, Benatti L, Tomasso L, Baldin G, Carnevali A, Querques L, Querques G, Bandello F. Comparison of the Performance of Two Different Spectral-Domain Optical Coherence Tomography Angiography Devices in Clinical Practice. Ophthalmic Res. 2016;56(3):155-62. doi: 10.1159/000447094. Epub 2016 Jul 12.

  PMID: 27399271 BACKGROUND

• Shin JW, Sung KR, Lee JY, Kwon J, Seong M. Optical coherence tomography angiography vessel density mapping at various retinal layers in healthy and normal tension glaucoma eyes. Graefes Arch Clin Exp Ophthalmol. 2017 Jun;255(6):1193-1202. doi: 10.1007/s00417-017-3671-4. Epub 2017 Apr 20.

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• Choi J, Kwon J, Shin JW, Lee J, Lee S, Kook MS. Quantitative optical coherence tomography angiography of macular vascular structure and foveal avascular zone in glaucoma. PLoS One. 2017 Sep 21;12(9):e0184948. doi: 10.1371/journal.pone.0184948. eCollection 2017.

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• Gadde SG, Anegondi N, Bhanushali D, Chidambara L, Yadav NK, Khurana A, Sinha Roy A. Quantification of Vessel Density in Retinal Optical Coherence Tomography Angiography Images Using Local Fractal Dimension. Invest Ophthalmol Vis Sci. 2016 Jan 1;57(1):246-52. doi: 10.1167/iovs.15-18287.

  PMID: 26803800 BACKGROUND

• Al-Sheikh M, Ghasemi Falavarjani K, Akil H, Sadda SR. Impact of image quality on OCT angiography based quantitative measurements. Int J Retina Vitreous. 2017 May 15;3:13. doi: 10.1186/s40942-017-0068-9. eCollection 2017.

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• Kim AY, Chu Z, Shahidzadeh A, Wang RK, Puliafito CA, Kashani AH. Quantifying Microvascular Density and Morphology in Diabetic Retinopathy Using Spectral-Domain Optical Coherence Tomography Angiography. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT362-70. doi: 10.1167/iovs.15-18904.

  PMID: 27409494 BACKGROUND

Study Officials

• Miklós Schneider, MD, PhD

  Semmelweis University, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor of Ophthalmology, Head of General Outpatient Unit

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 18, 2018
• Study Start: February 1, 2017
• Primary Completion: November 20, 2018
• Study Completion: March 30, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)