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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants; Patients With Cardiovascular Disease
• Intervention / Treatment: Diagnostic test: Retinal vascular assessment using OCTA and SLDF

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Bosch, MD; Phone Number: +49 9131 8536245; Email: agnes.bosch@uk-erlangen.de
• Study Contact Backup: Name: Dennis Kannenkeril, MD; Phone Number: +49 911 80099760; Email: CRC.M4@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • University of Erlangen Nuremberg
      • Contact: Agnes Bosch, MD; Phone Number: +49 9131 8536245; Email: CRC.M4@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Exclusion criteria for healthy individuals:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Assessment of retinal vessels; OCTA and SLDF based assessment of retinal vasculature	Diagnostic test: Retinal vascular assessment using OCTA and SLDF; Assessment of retinal capillary density using OCTA and SLDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: German Diabetes Association
• Investigators: Principal Investigator: Agnes Bosch, MD, Clinical Research Center, Department of Nephrology and Hypertension, Universityhospital Erlangen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: chronic kidney disease; heart failure; type 2 diabetes mellitus; arterial hypertension
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Heart Failure; Hypertension; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic
• Other Study ID Numbers: OCTA_CVD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No