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OpenTrials
Completed

NCT Number: NCT03357146

Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University, Department of Ophthalmology

Budapest, 1085, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical coherence tomography angiography

Device

OCTA scans per built-in device protocol

Primary outcomes

  1. Capillary density in relation to healthy subjects

    Time frame: Through study completion, 1 year

Secondary outcomes

  1. Correlation of capillary density and retinal thickness

    Time frame: Through study completion, 1 year

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Acronym: RAO-OCTA

Important dates

Study start
2017
Primary completion
2018
Study completion
2021
First posted
Nov 29, 2017
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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