Clinical trial NCT03357146: Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion
Official title: Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Artery Occlusion
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 42
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 caucasias

Brief summary: Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion with non-invasive, non-contact optical coherence tomography angiography.

Detailed description: Occlusion of the retinal arteries is an emergency which causes sudden, painless unilateral vision loss. Loss of blood flow causes ischemic damage to the retina. The extent of damage depends on the area affected.

Following the acute phase of the disease re-canalization occurs and lesser blood flow can be detected usually without functional recovery.

Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery occlusion.

Standard procedures to examine this disease include retinoscopy following pupil dilation, fluorescein angiography and more recently, optical coherence tomography (OCT).

The latest direction in OCT development was OCT angiography (OCTA) which is a software upgrade that allows detection of blood flow based on motion contrast. Similar to previous OCT machines OCTA is also non-invasive and non-contact and does not require any intravenous agents.

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:

* central or branch retinal artery occlusion
* at least 6 months of onset
* signed informed consent

Exclusion Criteria:

* known epilepsy
* incapacity
* presence of optical media opacities that would disturb the imaging
* presence of other retinal diseases that would disturb the evaluation of images

Primary outcomes:
measure: Capillary density in relation to healthy subjects
timeFrame: Through study completion, 1 year
Secondary outcomes:
measure: Correlation of capillary density and retinal thickness
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: Miklos Schneider
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Savastano MC, Lumbroso B, Rispoli M. IN VIVO CHARACTERIZATION OF RETINAL VASCULARIZATION MORPHOLOGY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2196-203. doi: 10.1097/IAE.0000000000000635.
citation: Spaide RF. VOLUME-RENDERED ANGIOGRAPHIC AND STRUCTURAL OPTICAL COHERENCE TOMOGRAPHY. Retina. 2015 Nov;35(11):2181-7. doi: 10.1097/IAE.0000000000000764.
citation: Yu S, Lu J, Cao D, Liu R, Liu B, Li T, Luo Y, Lu L. The role of optical coherence tomography angiography in fundus vascular abnormalities. BMC Ophthalmol. 2016 Jul 13;16:107. doi: 10.1186/s12886-016-0277-2.