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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• Men and women aged over 18 years

• Non-smokers

• Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

• Normal ophthalmic findings, ametropy \< 6 Dpt.

• Men and women aged over 18 years

• Non-smokers

• Previously diagnosed type II diabetes

• No, mild, moderate or severe non-proliferative diabetic retinopathy

• Normal ophthalmic findings except mild diabetic retinopathy, ametropy \< 6 Dpt.

Locations
Other Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna, Austria
RECRUITING
Vienna
Contact Information
Primary
Doreen Schmidl
doreen.schmidl@meduniwien.ac.at
+4314040029880
Backup
Kristina Stjepanek
kristina.stjepanek@meduniwien.ac.at
+4314040029880
Time Frame
Start Date: 2018-11-21
Estimated Completion Date: 2026-03-09
Participants
Target number of participants: 120
Treatments
Other: 30 patients with no signs of diabetic retinopathy
Other: 30 patients with mild diabetic retinopathy
Other: 30 patients with moderate to severe diabetic retinopathy
Other: 30 healthy age-and sex- matched control subjects
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov