NCT03357146

Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 42 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Retinal Artery Occlusion

Interventions

Type	Name	Description
DEVICE	Optical coherence tomography angiography	OCTA scans per built-in device protocol

Timeline

• Start date: 2017-01-09
• Primary completion: 2018-08-30
• Completion: 2021-08-30
• First posted: 2017-11-29
• Last updated: 2021-10-06

Locations

1 site across 1 country: Hungary

Regulatory

• FDA-regulated device study