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

Sponsor
Semmelweis University (Other)
Overall Status
Completed
CT.gov ID
NCT03357146
Collaborator
(none)
42
1
55.7
0.8

Study Details

Study Description

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 Phase
  • 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.

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion
Actual Study Start Date :
Jan 9, 2017
Actual Primary Completion Date :
Aug 30, 2018
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Capillary density in relation to healthy subjects [Through study completion, 1 year]

Secondary Outcome Measures

  1. Correlation of capillary density and retinal thickness [Through study completion, 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Semmelweis University, Department of Ophthalmology Budapest Hungary 1085

Sponsors and Collaborators

  • Semmelweis University

Investigators

  • Principal Investigator: Miklos Schneider, Semmelweis University, Department of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Miklos Schneider MD, PhD, Assistant Professor, Semmelweis University
ClinicalTrials.gov Identifier:
NCT03357146
Other Study ID Numbers:
  • RAO-OCTA-1253
First Posted:
Nov 29, 2017
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021