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

NCT01746615 | Unknown DMC

• 1 other identifier: OPHT-260612
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Retinal blood flow

  once on the study day

Secondary Outcomes (3)

• Retinal vessel diameter

  once on the study day

• Retinal blood velocity

  once on the study day

• Retinal oxygen saturation

  once on the study day

Study Arms (2)

30 Patients with BRVO in one eye

EXPERIMENTAL

Device: Dynamic Vessel Analyzer; Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)

30 healthy age and sex matched controls

EXPERIMENTAL

Device: Dynamic Vessel Analyzer; Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)

Interventions

Dynamic Vessel Analyzer DEVICE

retinal vessel diameter \& oxygen saturation

30 Patients with BRVO in one eye; 30 healthy age and sex matched controls

Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT) OTHER

retinal blood velocity

30 Patients with BRVO in one eye; 30 healthy age and sex matched controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gerhard Garhoefer, MD

CONTACT

+43140400; gerhard.garhoefer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: August 1, 2015
• Primary Completion: September 1, 2023
• Study Completion: September 2, 2023
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

AU (1)