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Measurement of Total Retinal Blood Flow and Oxygen Extraction in Patients With Diabetes and Healthy Subjects

Not Applicable
Conditions
Retinal Blood Flow
Interventions
Device: Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT)
Registration Number
NCT03552562
Lead Sponsor
Medical University of Vienna
Brief Summary

The prevalence of diabetes and diabetes-associated complications is still increasing. Several major long-term complications of diabetes such as cardiovascular disease, chronic renal failure, diabetic retinopathy and others relate to the damage of blood vessels. Given that the eye provides the unique possibility in the human body to directly visualize blood vessels, much interest has been directed towards studying the ocular circulation and retinal oxygen metabolism.

Although data of large epidemiological studies indicate that changes in retinal vessel caliber reflect other diabetes related factors, such as fasting glucose levels, there is still conflicting evidence on blood flow alterations in patients with diabetes. Strongly related to ocular blood flow, investigation of retinal oxygen metabolism has received a lot attention. In particular, hypoxia is assumed to be major trigger of neovascularisation in the retinal of diabetic patients The present study seeks to investigate both ocular blood flow and tissue oxygen extraction in patients with type II diabetes. For this purpose, total retinal blood flow will be assessed with bi-directional Fourier Domain Doppler Optical Coherence Tomography (FDOCT). Furthermore, retinal oxygen saturation will be measured non-invasively by a fundus camera based system. Based on data of retinal blood flow and retinal oxygen saturation, retinal oxygen. This will help to better understand ocular blood flow changes and oxygen metabolism in patients with type II diabetes.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
120
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
30 patients with mild diabetic retinopathyFourier Domain Color Doppler Optical Coherence Tomography (FDOCT)-
30 patients with moderate to severe diabetic retinopathyFourier Domain Color Doppler Optical Coherence Tomography (FDOCT)-
30 healthy age-and sex- matched control subjectsFourier Domain Color Doppler Optical Coherence Tomography (FDOCT)-
30 patients with no signs of diabetic retinopathyFourier Domain Color Doppler Optical Coherence Tomography (FDOCT)-
Primary Outcome Measures
NameTimeMethod
Total retinal blood flow (DVA and FDOCT)60 minutes

To determine the total blood flow in the eye, OCT measurements were performed with a rectangular scanning pattern around the optical nerve head.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna, Austria

🇦🇹

Vienna, Austria

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