HealthyNCT03590899
Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults
An observational study of Healthy, run by Semmelweis University at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteHungary
- Study dates
- 1 Feb 2017to 30 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: White Caucasian
Who may be able to join
- healthy patients without eye disease
Who cannot join
- incapacity
- any history or clinical evidence of retinal disease or glaucoma
- previous ocular surgery or laser photocoagulation
- optical media opacities that would disturb imaging
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Ophthalmology
Budapest, 1085
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Healthy volunteers without retinal disease, glaucoma, previous ocular surgery, laser photocoagulation, or optical media opacities that would disturb imaging. Receives: Device: Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, 1 year
Secondary outcomes (1)
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.
Measured: Through study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Feb 2017
- Primary completion20 Nov 2018
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Schneider MD, PhD, Semmelweis University
- Investigators
- Miklós Schneider, MD, PhD, Principal investigator, Semmelweis University, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590899
- Sponsor's protocol ID
- VESDEN-OCTA-1253
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25317632Kashani 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.
PubMed 28760677Coscas 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.
PubMed 27409475Corvi 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.
PubMed 29169882Matsunaga 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.
PubMed 25423629Tan 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.
PubMed 26098464Lupidi 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.
PubMed 27296485Weinhaus 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.
PubMed 7556462Mendis 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.
PubMed 20505200Agrawal 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.
PubMed 27176114Munk 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.
PubMed 28489918Zudaire 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.
PubMed 22110636Reif 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.
PubMed 22792084De 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.
PubMed 27399271Shin 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.
PubMed 28429123
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults
- ClinicalTrials.gov ID
- NCT03590899
- Acronym / sponsor ID
- VESDEN-OCTA-1253
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | – | Device: Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)Healthy volunteers without retinal disease, glaucoma, previous ocular surgery, laser photocoagulation, or optical media opacities that would disturb imaging. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- White Caucasian
Key inclusion criteria (1 listed)
- healthy patients without eye disease
Key exclusion criteria (4 listed)
- incapacity
- any history or clinical evidence of retinal disease or glaucoma
- previous ocular surgery or laser photocoagulation
- optical media opacities that would disturb imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Healthy patients |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Comparison of results obtained by the three quantification techniques
Time frame: Through study completion, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 25317632Spaide 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.
- Background: PubMed 28760677Kashani 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.
- Background: PubMed 27409475Coscas 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.
- Background: PubMed 29169882Corvi 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.
- Background: PubMed 25423629Matsunaga 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.
- Background: PubMed 26098464Tan 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.
- Background: PubMed 27296485Lupidi 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.
- Background: PubMed 7556462Weinhaus 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.
- Background: PubMed 20505200Mendis 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.
- Background: PubMed 27176114Agrawal 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.
- Background: PubMed 28489918Munk 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.
- Background: PubMed 22110636Zudaire 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miklós Schneider, MD, PhD principal investigator
Semmelweis University, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel density (VD) measured by Mexican Hat filtering technique (time frame: Through study completion, 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590899, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.