Back to resultsNon-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
Primary Purpose
Hypertensive Retinopathy
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Dynamic Vessel Analyzer
FDOCT
Ocular perfusion pressure
Sponsored by
About this trial
This is an interventional basic science trial for Hypertensive Retinopathy focused on measuring retinal blood flow, retinal blood velocity, retinal oxygen saturation, retinal vessel diameter, ocular perfusion pressure
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for healthy subjects
- Men and women aged over 18 years
- 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.
Inclusion criteria for patients with hypertensive retinopathy
- 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:
Any of the following will exclude a healthy subject from the study:
- 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
Sites / Locations
- Department of Clinical Pharmacology, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
hypertensive retinopathy
healthy controls
Arm Description
30 patients with hypertensive retinopathy stage 2 or 3
30 healthy age- and sex-matched controls
Outcomes
Primary Outcome Measures
Total retinal blood flow
Secondary Outcome Measures
Retinal vessel diameter
Retinal blood velocities
Ocular perfusion pressure
Retinal (arterial and venous) oxygen saturation
Full Information
NCT ID
NCT01753648
First Posted
December 7, 2012
Last Updated
April 6, 2022
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01753648
Brief Title
Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
Official Title
Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Recently, a new and sophisticated method for assessment of retinal blood flow and retinal blood flow velocity profiles has become available. This technique is based on the combination of measurement of retinal vessel calibers with bidirectional Fourier domain optical coherence tomography (FDOCT). The valid measurement of retinal blood flow is of significant importance, because it is known that major ophthalmic diseases, such as hypertensive retinopathy, are associated with alterations in blood flow.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Retinopathy
Keywords
retinal blood flow, retinal blood velocity, retinal oxygen saturation, retinal vessel diameter, ocular perfusion pressure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypertensive retinopathy
Arm Type
Experimental
Arm Description
30 patients with hypertensive retinopathy stage 2 or 3
Arm Title
healthy controls
Arm Type
Experimental
Arm Description
30 healthy age- and sex-matched controls
Intervention Type
Device
Intervention Name(s)
Dynamic Vessel Analyzer
Intervention Description
Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
Intervention Type
Other
Intervention Name(s)
FDOCT
Other Intervention Name(s)
Fourier Domain Color Doppler Optical Coherence Tomography
Intervention Description
total retinal blood flow (together with DVA), retinal blood velocities
Intervention Type
Other
Intervention Name(s)
Ocular perfusion pressure
Intervention Description
Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
Primary Outcome Measure Information:
Title
Total retinal blood flow
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Retinal vessel diameter
Time Frame
1 day
Title
Retinal blood velocities
Time Frame
1 day
Title
Ocular perfusion pressure
Time Frame
1 day
Title
Retinal (arterial and venous) oxygen saturation
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for healthy subjects
Men and women aged over 18 years
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.
Inclusion criteria for patients with hypertensive retinopathy
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:
Any of the following will exclude a healthy subject from the study:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhard Garhoefer, MD
Phone
+43140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhoefer, MD
Phone
+43140400
Ext
2981
Email
gerhard.garhoefer@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Katarzyna Napora, MD
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
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