Hypertensive RetinopathyNCT01753648
Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
A study testing Dynamic Vessel Analyzer, FDOCT and Ocular perfusion pressure in people with Hypertensive Retinopathy, run by Medical University of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertensive Retinopathy
- What is being tested?
- Dynamic Vessel Analyzer, FDOCT and Ocular perfusion pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhoefer, MD, +43140400 ext. 2981, gerhard.garhoefer@meduniwien.ac.at
Katarzyna Napora, MD
About this study
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.
- Conditions
- Hypertensive Retinopathy
- Being tested
- Dynamic Vessel Analyzer, FDOCT, Ocular perfusion pressure
- Keywords
- retinal blood flow, retinal blood velocity, retinal oxygen saturation, retinal vessel diameter, ocular perfusion pressure
- Medical subject headings
- Hypertensive Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Vessel AnalyzerDevice
Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
FDOCTOther
Also called Fourier Domain Color Doppler Optical Coherence Tomography
total retinal blood flow (together with DVA), retinal blood velocities
Ocular perfusion pressureOther
Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
| Study group | Role | What they receive |
|---|---|---|
| hypertensive retinopathy | Experimental | 30 patients with hypertensive retinopathy stage 2 or 3 Receives: Device: Dynamic Vessel Analyzer; Other: FDOCT; Other: Ocular perfusion pressure |
| healthy controls | Experimental | 30 healthy age- and sex-matched controls Receives: Device: Dynamic Vessel Analyzer; Other: FDOCT; Other: Ocular perfusion pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total retinal blood flow
Measured: 1 day
Secondary outcomes (4)
Retinal vessel diameter
Measured: 1 day
Retinal blood velocities
Measured: 1 day
Ocular perfusion pressure
Measured: 1 day
Retinal (arterial and venous) oxygen saturation
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startJan 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive RetinopathyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753648
- Sponsor's protocol ID
- OPHT-220612
- Status last verified
- Apr 2022
- First submitted
- 7 Dec 2012
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurement of Retinal Blood Flow Based on Vessel Analysis and Fourier Domain Optical Coherence Tomography in Patients With Hypertensive Retinopathy
- ClinicalTrials.gov ID
- NCT01753648
- Acronym / sponsor ID
- OPHT-220612
- Conditions
- Hypertensive Retinopathy
- Keywords
- retinal blood flow, retinal blood velocity, retinal oxygen saturation, retinal vessel diameter, ocular perfusion pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertensive retinopathy | Experimental | Device: Dynamic Vessel Analyzer, Other: FDOCT, Other: Ocular perfusion pressure30 patients with hypertensive retinopathy stage 2 or 3 |
| healthy controls | Experimental | Device: Dynamic Vessel Analyzer, Other: FDOCT, Other: Ocular perfusion pressure30 healthy age- and sex-matched controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Vessel AnalyzerRetinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation | Device | healthy controls, hypertensive retinopathy |
| FDOCTAlso: Fourier Domain Color Doppler Optical Coherence Tomographytotal retinal blood flow (together with DVA), retinal blood velocities | Other | healthy controls, hypertensive retinopathy |
| Ocular perfusion pressureMeasurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure | Other | healthy controls, hypertensive retinopathy |
Primary outcome
Total retinal blood flow
Time frame: 1 day
4 secondary outcomes
Retinal vessel diameter
Time frame: 1 day
Retinal blood velocities
Time frame: 1 day
Ocular perfusion pressure
Time frame: 1 day
Retinal (arterial and venous) oxygen saturation
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
Related trials for Hypertensive Retinopathy
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
RecruitingObservational study
"My Eyes, My Light": Amar Chokh, Amar Alo
Glaucoma, Diabetic Retinopathy (DR)
RecruitingObservational study
OCT in Rare Chorioretinal Diseases
Retinal Artery Occlusions, Polypoidal Choroidal Vasculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Vessel Analyzer, FDOCT and Ocular perfusion pressure in people with Hypertensive Retinopathy, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhoefer, MD (+43140400 ext. 2981, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total retinal blood flow (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.