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

Primary Purpose

Branch Retinal Vein Occlusion, Retinal Blood Flow, Retinal Oxygen Saturation

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Dynamic Vessel Analyzer
Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Branch Retinal Vein Occlusion focused on measuring branch retinal vein occlusion, dynamic vessel analyzer, fourier-domain OCT, retinal oxygen saturation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

30 Patients with BRVO in one eye

30 healthy age and sex matched controls

Arm Description

Outcomes

Primary Outcome Measures

Retinal blood flow

Secondary Outcome Measures

Retinal vessel diameter
Retinal blood velocity
Retinal oxygen saturation

Full Information

First Posted
December 7, 2012
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01746615
Brief Title
Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects
Official Title
Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Retinal Vein Occlusion, Retinal Blood Flow, Retinal Oxygen Saturation
Keywords
branch retinal vein occlusion, dynamic vessel analyzer, fourier-domain OCT, retinal oxygen saturation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
30 Patients with BRVO in one eye
Arm Type
Experimental
Arm Title
30 healthy age and sex matched controls
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Dynamic Vessel Analyzer
Intervention Description
retinal vessel diameter & oxygen saturation
Intervention Type
Other
Intervention Name(s)
Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)
Intervention Description
retinal blood velocity
Primary Outcome Measure Information:
Title
Retinal blood flow
Time Frame
once on the study day
Secondary Outcome Measure Information:
Title
Retinal vessel diameter
Time Frame
once on the study day
Title
Retinal blood velocity
Time Frame
once on the study day
Title
Retinal oxygen saturation
Time Frame
once on the study day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Garhoefer, MD
Phone
+43140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Phone
+43140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Katarzyna Napora, MD

12. IPD Sharing Statement

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

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