OCTA in Cardiovascular Disease and Healthy Controls
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Erlangen-Nürnberg Medical School
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Retinal vascular assessment using OCTA and SLDF
Diagnostic testAssessment of retinal capillary density using OCTA and SLDF
Treatment groups
64 Participants
are divided into 1 treatment groupGroup A: Assessment of retinal vesselsOther 1 intervention
Trial outcomes
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
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)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
Time frame
one study visit in each group, baseline values at day 1 are comparedSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Erlangen-Nürnberg Medical School
Lead sponsor
German Diabetes Association
Collaborator
Source ClinicalTrials.gov