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

Sponsor
Medical University of Vienna (Other)
Overall Status
Recruiting
CT.gov ID
NCT01746615
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
97.1
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dynamic Vessel Analyzer
  • Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects
Actual Study Start Date :
Aug 1, 2015
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 2, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Retinal blood flow [once on the study day]

Secondary Outcome Measures

  1. Retinal vessel diameter [once on the study day]

  2. Retinal blood velocity [once on the study day]

  3. Retinal oxygen saturation [once on the study day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01746615
Other Study ID Numbers:
  • OPHT-260612
First Posted:
Dec 11, 2012
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Keywords provided by Gerhard Garhofer, Assoc. Prof. PD Dr., Medical University of Vienna
branch retinal vein occlusion
dynamic vessel analyzer
fourier-domain OCT
retinal oxygen saturation
Additional relevant MeSH terms:
Retinal Vein Occlusion

Study Results

No Results Posted as of Apr 7, 2022