Actively Recruiting
Measurement of Total Retinal Blood Flow and Oxygen Extraction in Patients With Diabetes and Healthy Subjects
Led by Medical University of Vienna · Updated on 2025-05-23
120
Participants Needed
1
Research Sites
380 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Measurement of Total Retinal Blood Flow and Oxygen Extraction in Patients With Diabetes and Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged over 18 years
- Non-smokers
- Normal medical history unless considered clinically irrelevant by the investigator (for healthy subjects)
- Normal eye exam with ametropy less than 6 diopters (for healthy subjects)
- Previously diagnosed type II diabetes (for diabetic patients)
- No, mild, moderate, or severe non-proliferative diabetic retinopathy allowed (for diabetic patients)
- Normal eye exam except mild diabetic retinopathy with ametropy less than 6 diopters (for diabetic patients)
You will not qualify if you...
- Symptoms of a clinically relevant illness within 3 weeks before the first study day
- History or presence of a severe medical condition as judged by the investigator
- Regular medication use, alcohol abuse, or participation in another clinical trial within 3 weeks before the study (except oral contraceptives)
- Untreated arterial hypertension (systolic >145 mmHg or diastolic >90 mmHg)
- Blood donation within the previous 3 weeks
- History or family history of epilepsy
- Any abnormalities preventing reliable measurements in the study eye
- Best corrected visual acuity less than 0.8 Snellen
- Ametropy 6 diopters or higher
- Pregnancy, planned pregnancy, or breastfeeding
- Moderate to severe non-proliferative or proliferative diabetic retinopathy (for diabetic patients)
- Previous laser photocoagulation treatment (for diabetic patients)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Clinical Pharmacology, Medical University of Vienna, Austria
Vienna, Austria, 1090
Actively Recruiting
Research Team
D
Doreen Schmidl
CONTACT
K
Kristina Stjepanek
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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