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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590899
• Other study ID #: VESDEN-OCTA-1253
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: March 30, 2022

Study information

• Verified date: June 2022
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 30, 2022
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
Hungary	Semmelweis University, Department of Ophthalmology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kashani AH, Chen CL, Gahm JK, Zheng F, Richter GM, Rosenfeld PJ, Shi Y, Wang RK. Optical coherence tomography angiography: A comprehensive review of current methods and clinical applications. Prog Retin Eye Res. 2017 Sep;60:66-100. doi: 10.1016/j.preteyeres.2017.07.002. Epub 2017 Jul 29. Review. — View Citation

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. — View Citation

Lupidi M, Coscas F, Cagini C, Fiore T, Spaccini E, Fruttini D, Coscas G. Automated Quantitative Analysis of Retinal Microvasculature in Normal Eyes on Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Sep;169:9-23. doi: 10.1016/j.ajo.2016.06.008. Epub 2016 Jun 11. — View Citation

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. — View Citation

Mendis KR, Balaratnasingam C, Yu P, Barry CJ, McAllister IL, Cringle SJ, Yu DY. Correlation of histologic and clinical images to determine the diagnostic value of fluorescein angiography for studying retinal capillary detail. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5864-9. doi: 10.1167/iovs.10-5333. Epub 2010 May 26. — View Citation

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. — View Citation

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. — View Citation

Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. — View Citation

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. — View Citation

Spaide RF, Klancnik JM Jr, Cooney MJ. Retinal vascular layers imaged by fluorescein angiography and optical coherence tomography angiography. JAMA Ophthalmol. 2015 Jan;133(1):45-50. doi: 10.1001/jamaophthalmol.2014.3616. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Comparison of results obtained by the three quantification techniques	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