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Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion (RAO-OCTA)

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ClinicalTrials.gov Identifier: NCT03357146
Recruitment Status : Active, not recruiting
First Posted : November 29, 2017
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Miklos Schneider MD, PhD, 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.

Condition or disease Intervention/treatment
Retinal Artery Occlusion Device: 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.


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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 28, 2020

Group/Cohort Intervention/treatment
CRA
Patients with chronic retinal artery occlusion
Device: Optical coherence tomography angiography
OCTA scans per built-in device protocol

Control
Healthy
Device: Optical coherence tomography angiography
OCTA scans per built-in device protocol




Primary Outcome Measures :
  1. Capillary density in relation to healthy subjects [ Time Frame: Through study completion, 1 year ]

Secondary Outcome Measures :
  1. Correlation of capillary density and retinal thickness [ Time Frame: Through study completion, 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
White caucasias
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357146


Locations
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Hungary
Semmelweis University, Department of Ophthalmology
Budapest, Hungary, 1085
Sponsors and Collaborators
Semmelweis University
Investigators
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Principal Investigator: Miklos Schneider Semmelweis University, Department of Ophthalmology

Publications:

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Responsible Party: Miklos Schneider MD, PhD, Assistant Professor, Semmelweis University
ClinicalTrials.gov Identifier: NCT03357146     History of Changes
Other Study ID Numbers: RAO-OCTA-1253
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Retinal Artery Occlusion
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases