Branch Retinal Vein OcclusionNCT01746615
Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects
A study testing Dynamic Vessel Analyzer and Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT) in people with Branch Retinal Vein Occlusion and Retinal Blood Flow, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Branch Retinal Vein Occlusion, Retinal Blood Flow, Retinal Oxygen Saturation
- What is being tested?
- Dynamic Vessel Analyzer and Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)
- 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
- Aug 2015to 2 Sep 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 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
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- No history of BRVO in the fellow eye
- Temporal inferior or superior vein occlusion
- Ametropia < 6 Dpt
Who cannot join
- 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
Show all 12Show fewer
- 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
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
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.
Read more
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.
- Being tested
- Dynamic Vessel Analyzer, Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)
- Keywords
- branch retinal vein occlusion, dynamic vessel analyzer, fourier-domain OCT, retinal oxygen saturation
- Medical subject headings
- Retinal Vein Occlusion
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 \& oxygen saturation
Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)Other
retinal blood velocity
| Study group | Role | What they receive |
|---|---|---|
| 30 Patients with BRVO in one eye | Experimental | Not described Receives: Device: Dynamic Vessel Analyzer; Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT) |
| 30 healthy age and sex matched controls | Experimental | Not described Receives: Device: Dynamic Vessel Analyzer; Other: Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal blood flow
Measured: once on the study day
Secondary outcomes (3)
Retinal vessel diameter
Measured: once on the study day
Retinal blood velocity
Measured: once on the study day
Retinal oxygen saturation
Measured: once on the study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startAug 2015
- Primary completionSep 2023 (estimated)
- Study completion2 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branch Retinal Vein OcclusionStudies 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
- NCT01746615
- Sponsor's protocol ID
- OPHT-260612
- 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
- Assessment of Retinal Vessel Diameters and Red Blood Velocities in Patients With BRVO and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01746615
- Acronym / sponsor ID
- OPHT-260612
- Keywords
- branch retinal vein occlusion, dynamic vessel analyzer, fourier-domain OCT, retinal oxygen saturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- 2 Sep 2023 (estimated)
- First posted
- 11 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.
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.
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 |
|---|---|---|
| 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) |
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 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
Key exclusion criteria (12 listed)
- 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
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 \& oxygen saturation | Device | 30 Patients with BRVO in one eye, 30 healthy age and sex matched controls |
| Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)retinal blood velocity | Other | 30 Patients with BRVO in one eye, 30 healthy age and sex matched controls |
Primary outcome
Retinal blood flow
Time frame: once on the study day
3 secondary outcomes
Retinal vessel diameter
Time frame: once on the study day
Retinal blood velocity
Time frame: once on the study day
Retinal oxygen saturation
Time frame: once on the study 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.
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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 and Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT) in people with Branch Retinal Vein Occlusion and Retinal Blood Flow, 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 12 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?
Retinal blood flow (time frame: once on the study 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.