HealthyNCT02582411
Laser Speckle Flowgraphy in Caucasians: Age Dependence and Comparison With Doppler Optical Coherence Tomography
An observational study of Healthy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Some of the most prevalent eye diseases such as age-related macular degeneration, glaucoma and diabetic retinopathy are associated with ocular perfusion abnormalities. Currently, there is no gold-standard method for the measurement of ocular blood flow available. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Laser Speckle Flowgraphy and Doppler Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2015to Jan 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 healthy subjects in 4 age groups Group 1: 18-34 years Group 2: 35-49 years Group 3: 50-64 years Group 4: 65-80 years
Who may be able to join
- Men and women aged over 18 years, nonsmokers
- Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90- 99 mmHg diastolic) are eligible for participation in this study.
- Normal ophthalmic findings, ametropia < 6 Dpt
Who cannot join
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Wearing of contact lenses
- Ocular infection or clinically significant inflammation
- Ocular surgery in the 3 months preceding the study
- Blood donation in the 3 weeks preceding the study
- Pregnancy, planned pregnancy or lactating
- Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. Lens opacities classification system version II (LOCS-II) grading > 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Some of the most prevalent eye diseases such as age-related macular degeneration, glaucoma and diabetic retinopathy are associated with ocular perfusion abnormalities. Currently, there is no gold-standard method for the measurement of ocular blood flow available. Laser speckle flowgraphy is a promising technique for the two-dimensional assessment of ocular blood flow in humans. So far the technique has, however, been only gained widespread use in Japan. The experience in Caucasian subjects is very limited. In a Japanese population it was shown that mean blur rate, a measure of chorioretinal blood velocity, decreases with age. This is of relevance, because an age-related decline in ocular blood flow may partially explain the age-dependence of ocular vascular disease. The present study investigates this age-dependence in healthy subjects. In addition, the investigators investigate in a sub-group of this population whether relative flow volume (RFV), a novel index of blood flow in the human retina derived from laser speckle flowgraphy is associated with retinal blood flow as assessed with bi-directional Doppler Optical Coherence Tomography (DOCT).
- Conditions
- Healthy
- Being tested
- Laser Speckle Flowgraphy, Doppler Optical Coherence Tomography
- Keywords
- Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Speckle FlowgraphyDevice
Also called LSFG
A commercially available LSFG (Softcare, Fukutsu, Japan) system will be used in the present study. The LSFG device consists of a fundus camera equipped with a diode laser with a wavelength if 830 nm and charge-coupled device. NB, the relative velocity of blood flow, is derived from the pattern of speckle contrast produced by the interference of a laser scattered by blood cells moving in the ocular fundus. Images are acquired continuously at the rate of 30 frames per seconds in a 4-second time period and stored on a personal computer. Heartbeat map of the optic nerve head and the retina/choroid is generated
Doppler Optical Coherence TomographyDevice
A dual-beam bidirectional Doppler OCT system comprises a broadband superluminescent diode (SLD) with a central wavelength of 840 (spectral bandwidth 54 nm) and two CCD cameras with a maximum readout rate of 20 kHz. The system provides a resolution (in tissue) of about 6 and 18 μm in axial and lateral direction, respectively. The sample, i.e. the retinal vessel under study, is illuminated by two probe beams separated by their polarization properties. Light back scattered and backreflected from the sample is spectrally detected by two identical spectrometers and postprocessing, i.e.
calculation the phase shift due moving scatterers within the sample, is carried out by a personal computer with software written in National Instruments LabView. The power of both probe beams incident on the cornea is 650 μW, which is below the ANSI (American National Standard Institute) limits for small source ocular exposure to a laser beam within the measuring time.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 18-34 years | Patients in age group 18-34 years Receives: Device: Laser Speckle Flowgraphy; Device: Doppler Optical Coherence Tomography | |
| Group 2: 35-49 years | Patients in age group 35-49 years Receives: Device: Laser Speckle Flowgraphy | |
| Group 3: 50-64 years | Patients in age group 50-64 years Receives: Device: Laser Speckle Flowgraphy | |
| Group 4: 65-80 years | Patients in age group 65-80 years Receives: Device: Laser Speckle Flowgraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative flow volume (LSFG)
Measured: 3 weeks
Secondary outcomes (2)
Systemic blood pressure
Measured: 3 weeks
Intraocular pressure
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
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
- NCT02582411
- Sponsor's protocol ID
- OPHT-040415
- Status last verified
- Feb 2016
- First submitted
- 7 Oct 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
Publications
Luft N, Wozniak PA, Aschinger GC, Fondi K, Bata AM, Werkmeister RM, Schmidl D, Witkowska KJ, Bolz M, Garhofer G, Schmetterer L. Measurements of Retinal Perfusion Using Laser Speckle Flowgraphy and Doppler Optical Coherence Tomography. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5417-5425. doi: 10.1167/iovs.16-19896.
PubMed 27756076
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Speckle Flowgraphy in Caucasians: Age Dependence and Comparison With Doppler Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02582411
- Acronym / sponsor ID
- OPHT-040415
- Conditions
- Healthy
- Keywords
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- First posted
- 21 Oct 2015 (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.
Some of the most prevalent eye diseases such as age-related macular degeneration, glaucoma and diabetic retinopathy are associated with ocular perfusion abnormalities. Currently, there is no gold-standard method for the measurement of ocular blood flow available. Laser speckle flowgraphy is a promising technique for the two-dimensional assessment of ocular blood flow in humans. So far the technique has, however, been only gained widespread use in Japan. The experience in Caucasian subjects is very limited. In a Japanese population it was shown that mean blur rate, a measure of chorioretinal blood velocity, decreases with age. This is of relevance, because an age-related decline in ocular blood flow may partially explain the age-dependence of ocular vascular disease. The present study investigates this age-dependence in healthy subjects. In addition, the investigators investigate in a sub-group of this population whether relative flow volume (RFV), a novel index of blood flow in the human retina derived from laser speckle flowgraphy is associated with retinal blood flow as assessed with bi-directional Doppler Optical Coherence Tomography (DOCT).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: 18-34 years | – | Device: Laser Speckle Flowgraphy, Device: Doppler Optical Coherence TomographyPatients in age group 18-34 years |
| Group 2: 35-49 years | – | Device: Laser Speckle FlowgraphyPatients in age group 35-49 years |
| Group 3: 50-64 years | – | Device: Laser Speckle FlowgraphyPatients in age group 50-64 years |
| Group 4: 65-80 years | – | Device: Laser Speckle FlowgraphyPatients in age group 65-80 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 healthy subjects in 4 age groups Group 1: 18-34 years Group 2: 35-49 years Group 3: 50-64 years Group 4: 65-80 years
Key inclusion criteria (3 listed)
- Men and women aged over 18 years, nonsmokers
- Subject is generally healthy with no current significant or a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination. A significant disorder is defined as a disease or medical condition associated with impaired health status, requiring regular or current medical treatment and/or follow up. For the purposes of this study, an investigator may classify a medical condition as a nonsignificant disorder despite the fact that the subject receives treatment. Subjects having controlled Stage 1 hypertension (blood pressure of 140-159 mmHg systolic and/or 90- 99 mmHg diastolic) are eligible for participation in this study.
- Normal ophthalmic findings, ametropia < 6 Dpt
Key exclusion criteria (7 listed)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Wearing of contact lenses
- Ocular infection or clinically significant inflammation
- Ocular surgery in the 3 months preceding the study
- Blood donation in the 3 weeks preceding the study
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 |
|---|---|---|
| Laser Speckle FlowgraphyAlso: LSFGA commercially available LSFG (Softcare, Fukutsu, Japan) system will be used in the present study. The LSFG device consists of a fundus camera equipped with a diode laser with a wavelength if 830 nm and charge-coupled device. NB, the relative velocity of blood flow, is derived from the pattern of speckle contrast produced by the interference of a laser scattered by blood cells moving in the ocular fundus. Images are acquired continuously at the rate of 30 frames per seconds in a 4-second time period and stored on a personal computer. Heartbeat map of the optic nerve head and the retina/choroid is generated | Device | Group 1: 18-34 years, Group 2: 35-49 years, Group 3: 50-64 years, Group 4: 65-80 years |
| Doppler Optical Coherence TomographyA dual-beam bidirectional Doppler OCT system comprises a broadband superluminescent diode (SLD) with a central wavelength of 840 (spectral bandwidth 54 nm) and two CCD cameras with a maximum readout rate of 20 kHz. The system provides a resolution (in tissue) of about 6 and 18 μm in axial and lateral direction, respectively. The sample, i.e. the retinal vessel under study, is illuminated by two probe beams separated by their polarization properties. Light back scattered and backreflected from the sample is spectrally detected by two identical spectrometers and postprocessing, i.e. calculation the phase shift due moving scatterers within the sample, is carried out by a personal computer with software written in National Instruments LabView. The power of both probe beams incident on the cornea is 650 μW, which is below the ANSI (American National Standard Institute) limits for small source ocular exposure to a laser beam within the measuring time. | Device | Group 1: 18-34 years |
Primary outcome
Relative flow volume (LSFG)
Time frame: 3 weeks
2 secondary outcomes
Systemic blood pressure
Time frame: 3 weeks
Intraocular pressure
Time frame: 3 weeks
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 25 Feb 2016.
- Derived from this study: PubMed 27756076Luft N, Wozniak PA, Aschinger GC, Fondi K, Bata AM, Werkmeister RM, Schmidl D, Witkowska KJ, Bolz M, Garhofer G, Schmetterer L. Measurements of Retinal Perfusion Using Laser Speckle Flowgraphy and Doppler Optical Coherence Tomography. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5417-5425. doi: 10.1167/iovs.16-19896.
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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 Healthy, 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 3 inclusion and 7 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 25 Feb 2016. 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?
Relative flow volume (LSFG) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02582411, which also lists 1 linked publication.
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 25 Feb 2016.