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NCT Number: NCT07359664

OCTA in Cardiovascular Disease and Healthy Controls

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retinal vascular assessment using OCTA and SLDF

Diagnostic Test

Assessment of retinal capillary density using OCTA and SLDF

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    comparison of OCTA based retinal capillary density between CV diseased patients and healthy controls

Study contacts

Contact information is provided by the study sponsor or research team.

Agnes Bosch, MD

CONTACT

[email protected]

+49 9131 8536245

Dennis Kannenkeril, MD

CONTACT

[email protected]

+49 911 80099760

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • German Diabetes Association

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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