Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2012
CompletedFirst Posted
Study publicly available on registry
December 20, 2012
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 7, 2022
April 1, 2022
8.9 years
December 7, 2012
April 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total retinal blood flow
1 day
Secondary Outcomes (4)
Retinal vessel diameter
1 day
Retinal blood velocities
1 day
Ocular perfusion pressure
1 day
Retinal (arterial and venous) oxygen saturation
1 day
Study Arms (2)
hypertensive retinopathy
EXPERIMENTAL30 patients with hypertensive retinopathy stage 2 or 3
healthy controls
EXPERIMENTAL30 healthy age- and sex-matched controls
Interventions
Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
total retinal blood flow (together with DVA), retinal blood velocities
Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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 20, 2012
Study Start
January 1, 2015
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
April 7, 2022
Record last verified: 2022-04