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

NCT02582411 | Completed

• 1 other identifier: OPHT-040415
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Relative flow volume (LSFG)

  3 weeks

Secondary Outcomes (2)

• Systemic blood pressure

  3 weeks

• Intraocular pressure

  3 weeks

Study Arms (4)

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

Laser Speckle Flowgraphy DEVICE

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

Group 1: 18-34 years; Group 2: 35-49 years; Group 3: 50-64 years; Group 4: 65-80 years

Doppler Optical Coherence Tomography DEVICE

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.

Group 1: 18-34 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 27756076 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 21, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2016
• Last Updated: February 25, 2016

Record last verified: 2016-02

Locations

AU (1)