Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
NCT ID: NCT01753648
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-01-31
2023-12-31
Brief Summary
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Hypertensive retinopathy is the most common manifestation of arterial hypertension in the eye. Elevated systemic blood pressure leads to generalized arteriolar narrowing caused by vasospasms and increased vascular tone. Further in the disease process, focal arteriolar narrowing, retinal haemorrhages, hard exudates and cotton wool spots can occur. Previous studies have shown that blood flow in the extraocular vessels and in the choroid is compromised in patients with arterial hypertension. However, data on the impact of arterial hypertension on retinal blood flow and retinal blood flow velocities are lacking.
The present study sets out to compare total retinal blood flow and retinal velocity profiles in patients with hypertensive retinopathy and healthy age- and sex-matched controls. Ocular perfusion pressure will be calculated based on measurements of blood pressure and intraocular pressure to allow for calculation of vascular resistance. In addition, velocity profiles at arterio-venous crossings will be measured. It is hypothesized that these velocity profiles are considerably modified in patients with stage 2 and 3 hypertensive retinopathy compared to healthy controls because of pronounced arterio-venous compression.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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hypertensive retinopathy
30 patients with hypertensive retinopathy stage 2 or 3
Dynamic Vessel Analyzer
Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
FDOCT
total retinal blood flow (together with DVA), retinal blood velocities
Ocular perfusion pressure
Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
healthy controls
30 healthy age- and sex-matched controls
Dynamic Vessel Analyzer
Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
FDOCT
total retinal blood flow (together with DVA), retinal blood velocities
Ocular perfusion pressure
Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
Interventions
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Dynamic Vessel Analyzer
Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
FDOCT
total retinal blood flow (together with DVA), retinal blood velocities
Ocular perfusion pressure
Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Non-smokers
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Systolic Blood Pressure ≤ 120 mmHg and Diastolic Blood Pressure ≤ 80 mmHg
* Normal ophthalmic findings, ametropia \< 6 Dpt.
* Men and women aged over 18 years
* Hypertensive retinopathy stage 2 or 3
* Normal ophthalmic findings except hypertensive retinopathy stage 2 and 3, ametropia \< 6 Dpt.
Exclusion Criteria
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition as judged by the clinical investigator
* Presence or history of arterial hypertension
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
* Blood donation during the previous three weeks
* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
* Ametropia \>= 6 Dpt
* Pregnancy, planned pregnancy or lactating
Any of the following will exclude a patient with hypertensive retinopathy from the study:
* Participation in a clinical trial in the 3 weeks preceding the screening visit
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition as judged by the clinical investigator
* Blood donation during the previous three weeks
* Hypertensive retinopathy stage 4
* Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
* Ametropia \>= 6 Dpt
* Pregnancy, planned pregnancy or lactating
18 Years
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Gerhard Garhofer
Assoc. Prof. PD Dr.
Locations
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Department of Clinical Pharmacology, Medical University of Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OPHT-220612
Identifier Type: -
Identifier Source: org_study_id
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