OCTA in Cardiovascular Disease and Healthy Controls

NCT07359664 | Recruiting

• 1 other identifier: OCTA_CVD
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Cardiovascular Disease; Healthy Participants

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Assessment of retinal vessels

OTHER

OCTA and SLDF based assessment of retinal vasculature

Diagnostic Test: Retinal vascular assessment using OCTA and SLDF

Interventions

Retinal vascular assessment using OCTA and SLDF DIAGNOSTIC_TEST

Assessment of retinal capillary density using OCTA and SLDF

Assessment of retinal vessels

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cardiovascular disease defined as one or more of the following: arterial hypertension, type 2 diabetes mellitus, chronic kidney disease, heart failure
• 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.

You may not qualify if:

• Active ophthalmological (retinal) disease resulting in impaired visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).
• 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
• alcohol or drug abuse

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• German Diabetes Association: collaborator

Study Sites (1)

University of Erlangen Nuremberg

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Heart Failure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases

Study Officials

• Agnes Bosch, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnes Bosch, MD

CONTACT

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

Dennis Kannenkeril, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Assessment of OCTA and SLDF in all patients/healthy individuals

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 22, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)