Measuring blood flow and oxygen levels in the retina of diabetic and healthy individuals
Measurement of Total Retinal Blood Flow and Oxygen Extraction in Patients With Diabetes and Healthy Subjects
This study is testing how diabetes affects blood flow and oxygen levels in the eyes compared to healthy people to better understand potential complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT03552562 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a diagnosis of type II diabetes and mild diabetic retinopathy.
Not a fit: Patients with severe non-proliferative diabetic retinopathy or other significant ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of diabetic retinopathy and improve management strategies for patients with diabetes.
How similar studies have performed: Other studies have shown promise in investigating retinal blood flow and oxygen metabolism in diabetic patients, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.