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

  • STATUS
    Recruiting
  • End date
    Apr 22, 2023
  • participants needed
    120
  • sponsor
    Medical University of Vienna
Updated on 22 April 2022
Accepts healthy volunteers

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.

Details
Condition Retinal Blood Flow
Treatment Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT)
Clinical Study IdentifierNCT03552562
SponsorMedical University of Vienna
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Inclusion criteria for patients with diabetes
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

Exclusion Criteria

Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Presence or history of a severe medical condition as judged by the clinical investigator
Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
untreated arterial hypertension (defined as either systolic blood pressure >145 mmHg or diastolic blood pressure >90 mmHg)
Blood donation during the previous three weeks
History or family history of epilepsy
Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
Best corrected visual acuity < 0.8 Snellen
Ametropy ≥ 6 Dpt
Pregnancy, planned pregnancy or lactating
Exclusion Criteria for patients with diabetes
Participation in a clinical trial in the 3 weeks preceding the screening visit
Symptoms of a clinically relevant illness in the 3 weeks before the first study day
Presence or history of a severe medical condition, except diabetes, as judged by the clinical investigator
untreated arterial hypertension (defined as either systolic blood pressure >145 mmHg or diastolic blood pressure >90 mmHg)
Blood donation during the previous three weeks
Moderate to severe non-proliferative or proliferative diabetic retinopathy
Previous laser photocoagulation treatment
History or family history of epilepsy
Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
Best corrected visual acuity < 0.8 Snellen
Ametropy ≥ 6 Dpt
Pregnancy, planned pregnancy or lactating
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