Clinical trial NCT03590899: Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults
Official title: Semi-manual Vessel Density Analysis on Optical Coherence Tomography Angiography Images of Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: White Caucasian

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.

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.

Eligibility 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

Primary outcomes:
measure: Vessel density (VD) measured by Mexican Hat filtering technique
timeFrame: Through study completion, 1 year
measure: Skeleton density (SD) measured by Mexican Hat filtering technique
timeFrame: Through study completion, 1 year
measure: Vessel diameter index (VDI) measured by Mexican Hat filtering technique
timeFrame: Through study completion, 1 year
measure: Vessel density (VD) measured by Shanbag tresholding technique
timeFrame: Through study completion, 1 year
measure: Skeleton density (SD) measured by Shanbag tresholding technique
timeFrame: Through study completion, 1 year
measure: Vessel diameter index (VDI) measured by Shanbag tresholding technique
timeFrame: Through study completion, 1 year
measure: Vessel density (VD) measured by Angioplex Metrix
timeFrame: Through study completion, 1 year
measure: Skeleton density (SD) measured by Angioplex Metrix
timeFrame: Through study completion, 1 year
Secondary outcomes:
measure: Comparison of results obtained by the three quantification techniques
timeFrame: Through study completion, 1 year
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Ophthalmology
Study officials:
affiliation: Semmelweis University, Department of Ophthalmology
name: Miklós Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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