Measuring blood flow and oxygen levels in the retina of diabetic and healthy individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the total retinal blood flow and oxygen extraction in patients with diabetes compared to healthy subjects. Utilizing Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT), the research aims to understand the relationship between retinal blood flow alterations and diabetes-related factors. By directly visualizing the ocular circulation, the study seeks to provide insights into how diabetes affects retinal oxygen metabolism and potentially triggers complications like neovascularization. The findings could help clarify conflicting evidence regarding blood flow changes in diabetic patients.

Why it matters

Who can join: the full rules

Inclusion Criteria for healthy subjects:

* 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 for healthy subjects:

* 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

Where it's running

• Department of Clinical Pharmacology, Medical University of Vienna, Austria
  Vienna, Austria Recruiting

Study contacts

• Study coordinator: Doreen Schmidl
• Email: doreen.schmidl@meduniwien.ac.at
• Phone: +4314040029880

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.