Retinal Blood VesselsMIRNCT02717026
Multimodal Imaging of Retinal Vessels
An observational study of Retinal Blood Vessels and Age-Related Macular Degeneration, run by Medical University of Graz at 1 site in Austria.
Trial summary
Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial. Different imaging modalities might provide divergent results. Thus, quantification of such differences is valuable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Blood Vessels, Age-Related Macular Degeneration
- What is being tested?
- Optical coherence tomography, Fluorescein angiography and Fundus photography
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2015to Jan 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: adult patients scheduled for routine retinal assessment
Who may be able to join
- written informed consent, clear media
Who cannot join
- any abnormality preventing reliable vessel measurement, pregnancy,
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Ophthalmology, Medical University of Graz
Graz, Styria, 8036
About this study
Official title: Retinal Vessel Morphology in Multimodal Imaging
Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial. Different imaging modalities might provide divergent results. Thus, quantification of such differences is valuable.
The present study aims to reveal and quantify differences in vessel morphology between fundus photography, fundus angiography, and optical coherence tomography in health and disease.
Read the detailed description
This is considered a pilot study and will pe performed on patients scheduled for routine fluorescein angiography.
During the study day the following procedures will be performed:
- Medical history and concomitant medication
- Blood pressure and heart rate
- Assessment of visual acuity using Snellen vision charts
- Biomicroscopy
- Intraocular pressure
- Funduscopy
- IOL-Master axial length measurement
- Fundusphotography
- Optical coherence tomography
- Fluorescein Angiography Fundus photography analysis will be performed with an automated software and analysis of both angiography and optical coherence tomography will be performed via the devices inbuilt software.
- Being tested
- Optical coherence tomography, Fluorescein angiography, Fundus photography
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyDevice
Sections including the retinal vasculature will be taken.
Fluorescein angiographyDevice
Video fluorescein angiography from one eye of each subject will be performed
Fundus photographyDevice
30 and 50 degree fundus images
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal vessel diameter
Measured: 5 minutes
Secondary outcomes (1)
retinal vessel reflectivity
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Blood VesselsStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717026
- Sponsor's protocol ID
- 27-262ex14/15
- Acronym
- MIR
- Status last verified
- Sep 2020
- First submitted
- 7 Sep 2015
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vessel Morphology in Multimodal Imaging
- ClinicalTrials.gov ID
- NCT02717026
- Acronym / sponsor ID
- MIR / 27-262ex14/15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 23 Mar 2016 (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.
Retinal blood flow measurement is of scientific and clinical value. For this purpose retinal vessel morphology (such as diameter, vessel wall thickness, etc) determination is crucial. Different imaging modalities might provide divergent results. Thus, quantification of such differences is valuable.
The present study aims to reveal and quantify differences in vessel morphology between fundus photography, fundus angiography, and optical coherence tomography in health and disease.
Detailed description
This is considered a pilot study and will pe performed on patients scheduled for routine fluorescein angiography.
During the study day the following procedures will be performed:
- Medical history and concomitant medication
- Blood pressure and heart rate
- Assessment of visual acuity using Snellen vision charts
- Biomicroscopy
- Intraocular pressure
- Funduscopy
- IOL-Master axial length measurement
- Fundusphotography
- Optical coherence tomography
- Fluorescein Angiography Fundus photography analysis will be performed with an automated software and analysis of both angiography and optical coherence tomography will be performed via the devices inbuilt software.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients scheduled for routine retinal assessment
Key inclusion criteria (1 listed)
- written informed consent, clear media
Key exclusion criteria (1 listed)
- any abnormality preventing reliable vessel measurement, pregnancy,
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 |
|---|---|---|
| Optical coherence tomographySections including the retinal vasculature will be taken. | Device | – |
| Fluorescein angiographyVideo fluorescein angiography from one eye of each subject will be performed | Device | – |
| Fundus photography30 and 50 degree fundus images | Device | – |
Primary outcome
retinal vessel diameter
Time frame: 5 minutes
1 secondary outcome
retinal vessel reflectivity
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Blood Vessels and Age-Related Macular Degeneration, run by Medical University of Graz 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal vessel diameter (time frame: 5 minutes). 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 14 Sep 2020.