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| Name | Class |
|---|---|
| German Diabetes Association | OTHER |
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This prospective clinical study will involve the non-invasive assessment of retinal vessels using OCTA (Cirrus OCT 6000 AngioPlex) and scanning laser Doppler flowmetry (SLDF) in patients with cardiovascular disease and healthy individuals. The study will be conducted at the Clinical Research Centre (CRC), Department of Nephrology and Hypertension at the University of Erlangen-Nuremberg.
Each patient (32 patients) and healthy individual (32 healthy individuals) undergoes one study visit. After providing informed consent, each patient and healthy individual receives an assessment of their retinal vessels using OCTA and SLDF. In the sub-study of 10 patients with cardiovascular disease, the reliability of the OCTA measurements will be determined. Each patient will receive three study visits (with an OCTA and SLDF assessment on each occasion) on three different days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment of retinal vessels | Other | OCTA and SLDF based assessment of retinal vasculature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retinal vascular assessment using OCTA and SLDF | Diagnostic Test | Assessment of retinal capillary density using OCTA and SLDF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of reliability of OCTA based assessment of retinal capillary density in patients with CV disease | Assessment of test-retest-reliability between 3 study visits for OCTA based assessment of retinal capillary density in patients with CV disease | test-retest-reliability between 3 study visits (between each visit needs to be a time gap of at least 24 hours, all visits will be performed within two weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of OCTA based retinal capillary density between CV diseased patients and healthy controls | comparison of OCTA based retinal capillary density between CV diseased patients and healthy controls | one study visit in each group, baseline values at day 1 are compared |
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Inclusion Criteria for patients with cardiovascular disease:
Inclusion Criteria for healthy individuals:
Exclusion criteria for patients with cardiovascular disease:
Exclusion criteria for healthy individuals:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnes Bosch, MD | Contact | +49 9131 8536245 | agnes.bosch@uk-erlangen.de | |
| Dennis Kannenkeril, MD | Contact | +49 911 80099760 | CRC.M4@uk-erlangen.de |
| Name | Affiliation | Role |
|---|---|---|
| Agnes Bosch, MD | Clinical Research Center, Department of Nephrology and Hypertension, Universityhospital Erlangen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Erlangen Nuremberg | Recruiting | Erlangen | Bavaria | 91054 | Germany |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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Assessment of OCTA and SLDF in all patients/healthy individuals
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |