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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01746615
Enrollment
60
Registered
2012-12-11
Start date
2015-08-31
Completion date
2023-09-02
Last updated
2022-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

branch retinal vein occlusion, dynamic vessel analyzer, fourier-domain OCT, retinal oxygen saturation

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.

Interventions

retinal vessel diameter & oxygen saturation

OTHERBidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)

retinal blood velocity

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Retinal blood flowonce on the study day

Secondary

MeasureTime frame
Retinal vessel diameteronce on the study day
Retinal blood velocityonce on the study day
Retinal oxygen saturationonce on the study day

Countries

Austria

Contacts

Primary ContactGerhard Garhoefer, MD
gerhard.garhoefer@meduniwien.ac.at+43140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026