Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects

April 6, 2022 updated by: Gerhard Garhofer, Medical University of Vienna

Assessment of retinal vessel calibers combined with bidirectional Fourier domain optical coherence tomography (FDOCT) for measurement of retinal blood velocities is a new and sophisticated method for assessing retinal blood flow in humans. The valid measurement of retinal blood flow is of significant importance, because it is known that major ophthalmic diseases are associated with alterations in blood flow.

As such, retinal vascular occlusive diseases represent a major cause of visual impairment and blindness. The prevalence of the disease is between 0.7 and 1.6%. Compression of the retinal veins at arterio-venous (AV) crossings plays an important role in the development of branch retinal vein occlusion (BRVO). The mechanical narrowing of the vessel lumen is supposed to be the mechanism behind this fact. The present study should elucidate how BRVO influences retinal blood flow at retinal vessel crossings in comparison to healthy control subjects. Retinal blood flow at retinal bifurcations will also be assessed. In addition, a fundus image will be taken to assess retinal oxygen saturation.

For the first time we use a combination of a dynamic vessel analyzer (DVA) with bidirectional Fourier domain optical coherence tomography (FDOCT) to assess retinal blood flow. Whereas the DVA provides information concerning retinal vessel caliber, FDOCT provides laser Doppler information in addition to conventional optical coherence tomography, allowing the observation of blood flow dynamics simultaneously.

In the present study we hypothesize that the DVA in combination with FDOCT is a suitable new tool for the assessment of blood flow in healthy subjects and in patients with BRVO.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria for healthy subjects

  • Men and women aged over 18 yrs
  • Nonsmokers
  • Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia < 6 Dpt.

Inclusion criteria for patients with BRVO

  • Age ≥ 18a
  • Patients with branch retinal vein occlusion with a history of 3 to 9 months in one eye
  • No history of BRVO in the fellow eye
  • Temporal inferior or superior vein occlusion
  • Ametropia < 6 Dpt

Exclusion Criteria:

Any of the following will exclude a healthy subject from the study:

  • Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Blood donation during the previous 3 weeks
  • Pregnancy
  • Any abnormalities preventing reliable measurements as judged by the investigator

Any of the following will exclude a patient with BRVO from the study:

  • Presence of intraocular pathology other than branch retinal vein occlusion
  • Blood donation during the previous 3 weeks
  • Clinical trial in the 3 week preceding the study
  • Pregnancy
  • Any abnormalities preventing reliable measurements as judged by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 30 Patients with BRVO in one eye
Device: Dynamic Vessel Analyzer
retinal vessel diameter & oxygen saturation
Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)
retinal blood velocity
EXPERIMENTAL: 30 healthy age and sex matched controls
Device: Dynamic Vessel Analyzer
retinal vessel diameter & oxygen saturation
Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)
retinal blood velocity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal blood flow
Time Frame: once on the study day
once on the study day

Secondary Outcome Measures

Outcome Measure
Time Frame
Retinal vessel diameter
Time Frame: once on the study day
once on the study day
Retinal blood velocity
Time Frame: once on the study day
once on the study day
Retinal oxygen saturation
Time Frame: once on the study day
once on the study day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 2, 2023

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-260612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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