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CompletedNCT02582411Updated Feb 25, 2016

Laser Speckle Flowgraphy in Caucasians: Age Dependence and Comparison With Doppler Optical Coherence Tomography

An observational study in Healthy, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-25.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
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Study 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. 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).

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Conditions studied

  • Healthy

Keywords

  • Healthy Subjects
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In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1: 18-34 years

    Patients in age group 18-34 years

    Device: Laser Speckle Flowgraphy · Device: Doppler Optical Coherence Tomography

  • Group 2: 35-49 years

    Patients in age group 35-49 years

    Device: Laser Speckle Flowgraphy

  • Group 3: 50-64 years

    Patients in age group 50-64 years

    Device: Laser Speckle Flowgraphy

  • Group 4: 65-80 years

    Patients in age group 65-80 years

    Device: Laser Speckle Flowgraphy

Interventions

  • DeviceLaser Speckle Flowgraphy

    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

    Also known as: LSFG

  • DeviceDoppler Optical Coherence Tomography

    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.

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What researchers measure

Primary outcomes

  1. Relative flow volume (LSFG)

    Time frame: 3 weeks

Secondary outcomes

  1. Systemic blood pressure

    Time frame: 3 weeks

  2. Intraocular pressure

    Time frame: 3 weeks

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Study locations

1 site
  • Department of Clinical Pharmacology, Medical University of Vienna
    Vienna, 1090, Austria
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02582411
Lead sponsor
Medical University of Vienna
Responsible party
Gerhard Garhofer (Assoc. Prof. PD Dr., Medical University of Vienna) — Principal investigator
First posted
Oct 21, 2015
Start date
Aug 2015
Primary completion
Jan 2016
Last update
Feb 25, 2016
View the source record on ClinicalTrials.gov ↗

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