OCTA in Cardiovascular Disease and Healthy Controls

Optical Coherence Tomography Angiography (OCTA) for the Assessment of Retinal Capillary Density in Patients With Cardiovascular Disease and a Healthy Control Group

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07359664

Enrollment

Registered

2026-01-22

Start date

2025-12-01

Completion date

2027-03-01

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants, Patients With Cardiovascular Disease

Keywords

arterial hypertension, type 2 diabetes mellitus, chronic kidney disease, heart failure

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTRetinal vascular assessment using OCTA and SLDF

Assessment of retinal capillary density using OCTA and SLDF

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Assessment of OCTA and SLDF in all patients/healthy individuals

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

for patients with cardiovascular disease: * cardiovascular disease defined as one or more of the following: arterial hypertension, type 2 diabetes mellitus, chronic kidney disease, heart failure Inclusion Criteria for healthy individuals: * 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).

Design outcomes

Primary

Measure	Time frame	Description
Assessment of reliability of 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)	Assessment of test-retest-reliability between 3 study visits for OCTA based assessment of retinal capillary density in patients with CV disease

Secondary

Measure	Time frame	Description
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	comparison of OCTA based retinal capillary density between CV diseased patients and healthy controls

Countries

Germany

Contacts

CONTACTAgnes Bosch, MD

agnes.bosch@uk-erlangen.de+49 9131 8536245

CONTACTDennis Kannenkeril, MD

CRC.M4@uk-erlangen.de+49 911 80099760

PRINCIPAL_INVESTIGATORAgnes Bosch, MD

Clinical Research Center, Department of Nephrology and Hypertension, Universityhospital Erlangen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026