Patients With Cardiovascular DiseaseNCT07359664
OCTA in Cardiovascular Disease and Healthy Controls
A study testing Retinal vascular assessment using OCTA and SLDF in people with Patients With Cardiovascular Disease and Healthy Participants, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Cardiovascular Disease, Healthy Participants
- What is being tested?
- Retinal vascular assessment using OCTA and SLDF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18-29.9 kg/m2
- Non-smoker
- Good general health, as determined by study personnel based on assessments of previous visits, including anamnesis, vital signs, physical examination and clinical laboratory parameters.
- Exclusion criteria for patients with cardiovascular disease:
- Active ophthalmological (retinal) disease resulting in impaired visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).
Who cannot join
- Active ophthalmological (retinal) disease with reduced visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).
- clinically relevant deviation in physical examination, vital signs, or laboratory parameters (based on the physician's clinical judgement).
- a clinically relevant history of cardiovascular disease or any other previously known cardiovascular disease
- History of clinically relevant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine or other diseases
- office blood pressure above or equal to 140/90 mmHg
- Office heart rate outside of the following range: 50-99 bpm
- regular intake of any medication for the treatment of cardiovascular diseases (e.g. antihypertensive or antidiabetic medication) within one month before study inclusion
- alcohol or drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Erlangen Nuremberg
Erlangen, Bavaria, 91054
Agnes Bosch, MD, +49 9131 8536245, CRC.M4@uk-erlangen.de
About this study
Official title: Optical Coherence Tomography Angiography (OCTA) for the Assessment of Retinal Capillary Density in Patients With Cardiovascular Disease and a Healthy Control Group
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.
Read the detailed description
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.
- Being tested
- Retinal vascular assessment using OCTA and SLDF
- Keywords
- arterial hypertension, type 2 diabetes mellitus, chronic kidney disease, heart failure
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal vascular assessment using OCTA and SLDFDiagnostic test
Assessment of retinal capillary density using OCTA and SLDF
| Study group | Role | What they receive |
|---|---|---|
| Assessment of retinal vessels | Other | OCTA and SLDF based assessment of retinal vasculature Receives: Diagnostic Test: Retinal vascular assessment using OCTA and SLDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Secondary outcomes (1)
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
Measured: one study visit in each group, baseline values at day 1 are compared
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assessment of OCTA and SLDF in all patients/healthy individuals
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Agnes Bosch, MD, Principal investigator, Clinical Research Center, Department of Nephrology and Hypertension, Universityhospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359664
- Sponsor's protocol ID
- OCTA_CVD
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography (OCTA) for the Assessment of Retinal Capillary Density in Patients With Cardiovascular Disease and a Healthy Control Group
- ClinicalTrials.gov ID
- NCT07359664
- Acronym / sponsor ID
- OCTA_CVD
- Keywords
- arterial hypertension, type 2 diabetes mellitus, chronic kidney disease, heart failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- German Diabetes Association
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessment of OCTA and SLDF in all patients/healthy individuals
| Arm | Type | Receives |
|---|---|---|
| Assessment of retinal vessels | Other | Diagnostic Test: Retinal vascular assessment using OCTA and SLDFOCTA and SLDF based assessment of retinal vasculature |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 18-29.9 kg/m2
- Non-smoker
- Good general health, as determined by study personnel based on assessments of previous visits, including anamnesis, vital signs, physical examination and clinical laboratory parameters.
- Active ophthalmological (retinal) disease resulting in impaired visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).
Key exclusion criteria (8 listed)
- Active ophthalmological (retinal) disease with reduced visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).
- clinically relevant deviation in physical examination, vital signs, or laboratory parameters (based on the physician's clinical judgement).
- a clinically relevant history of cardiovascular disease or any other previously known cardiovascular disease
- History of clinically relevant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine or other diseases
- office blood pressure above or equal to 140/90 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal vascular assessment using OCTA and SLDFAssessment of retinal capillary density using OCTA and SLDF | Diagnostic test | Assessment of retinal vessels |
Primary outcome
Assessment of reliability of OCTA based assessment of retinal capillary density in patients with CV disease
Time frame: 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)
Assessment of test-retest-reliability between 3 study visits for OCTA based assessment of retinal capillary density in patients with CV disease
1 secondary outcome
comparison of OCTA based retinal capillary density between CV diseased patients and healthy controls
Time frame: one study visit in each group, baseline values at day 1 are compared
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnes Bosch, MD principal investigator
Clinical Research Center, Department of Nephrology and Hypertension, Universityhospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinal vascular assessment using OCTA and SLDF in people with Patients With Cardiovascular Disease and Healthy Participants, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnes Bosch, MD (+49 9131 8536245, agnes.bosch@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of reliability of OCTA based assessment of retinal capillary density in patients with CV disease (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.