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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Device: Dynamic Vessel Analyzer
* Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal blood flow |  | once on the study day | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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branch retinal vein occlusion, dynamic vessel analyzer, fourier-domain OCT, retinal oxygen saturation