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

Medical University of Vienna

Status

Enrolling

Conditions

Retinal Oxygen Saturation

Retinal Blood Flow

Branch Retinal Vein Occlusion

Treatments

Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)

Device: Dynamic Vessel Analyzer

Study type

Interventional

Funder types

Other

Identifiers

NCT01746615

OPHT-260612

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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