Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion

Completed

• Conditions: Retinal Artery Occlusion
• Interventions: Device: Optical coherence tomography angiography

• Registration Number: NCT03357146
• Lead Sponsor: Semmelweis University

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.

Study Timeline

• Study Start: 2017-01-09
• Study First Submitted: 2017-11-23
• Study First Submitted QC: 2017-11-28
• Study First Posted: 2017-11-29
• Primary Completion: 2018-08-30
• Study Completion: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRA	Optical coherence tomography angiography	Patients with chronic retinal artery occlusion
Control	Optical coherence tomography angiography	Healthy

Primary Outcome Measures

Name	Time	Method
Capillary density in relation to healthy subjects	Through study completion, 1 year

Secondary Outcome Measures

Name	Time	Method
Correlation of capillary density and retinal thickness	Through study completion, 1 year

Trial Locations

Locations (1)

Semmelweis University, Department of Ophthalmology; 🇭🇺 Budapest, Hungary