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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01746615
First received: December 7, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Branch Retinal Vein Occlusion
Retinal Blood Flow
Retinal Oxygen Saturation
Device: Dynamic Vessel Analyzer
Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Retinal blood flow [ Time Frame: once on the study day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retinal vessel diameter [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
  • Retinal blood velocity [ Time Frame: once on the study day ] [ Designated as safety issue: No ]
  • Retinal oxygen saturation [ Time Frame: once on the study day ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746615

Contacts
Contact: Gerhard Garhoefer, MD +43140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD    +43140400 ext 2981    gerhard.garhoefer@meduniwien.ac.at   
Principal Investigator: Katarzyna Napora, MD         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01746615     History of Changes
Other Study ID Numbers: OPHT-260612
Study First Received: December 7, 2012
Last Updated: December 7, 2012
Health Authority: Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medical University of Vienna:
branch retinal vein occlusion
dynamic vessel analyzer
fourier-domain OCT
retinal oxygen saturation

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014