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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582411
• Other study ID #: OPHT-040415
• Status: Completed
• Phase: N/A
• First received: October 7, 2015
• Last updated: February 24, 2016
• Start date: August 2015

Study information

• Verified date: February 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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:

• 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)

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Laser 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
• Doppler 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.

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative flow volume (LSFG)		3 weeks	No
Secondary	Systemic blood pressure		3 weeks	No
Secondary	Intraocular pressure		3 weeks	No