An interventional study of Optical Coherence Tomography Angiography and Blood test in Retinal Vascular, Retinal Disease and Retinal Ischemia, sponsored by Hospital Clinic of Barcelona. Status unknown at 2 sites in Spain. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by Hospital Clinic of Barcelona · Not applicable, Interventional, and Diagnostic
This study is directed to evaluate the role of Optical Coherence Tomography Angiography (OCT-A) in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.
Diabetic retinopathy (DR) is the leading cause of blindness in type 1 Diabetes Mellitus (DM) patients, as a consequence of impaired blood flow in the retina. Optical coherence tomography angiography (OCT-A) is a newly developed, non-invasive, retinal imaging technique that allows detection of perfused and non perfused areas of the retina without the injection of dye. This OCT-based method permits adequate delineation of the perifoveal vascular network, and allows objective identification of microvascular changes, such as capillary dilation or presence of microaneurisms. It is also capable to detect paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (FAZ), representing an excellent tool for assessment of diabetic retinopathy.
Given that all these features are commonly seen in diabetic patients, the relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still need to be elucidated. Interestingly, further studies are required to investigate whether these changes reflect those occurring elsewhere in the body affected by diabetic microvascular disease, as the kidneys or the brain. If these relationships were demonstrated, early detection of these microvascular changes could lead to modifications in the pharmacological management of diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs. The aim of this study is to evaluate the role of OCT-A in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between these OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.
Exclusion Criteria:
Cohort of Type 1 DM patients
Diagnostic Test: Optical Coherence Tomography Angiography · Diagnostic Test: Blood test · Diagnostic Test: Urine test
Cohort of Healthy controls
Diagnostic Test: Optical Coherence Tomography Angiography · Diagnostic Test: Blood test · Diagnostic Test: Urine test
Optical Coherence Tomography Angiography images capture.
Blood test, systemic markers
Urine test, systemic markers
Perifoveal vessel density
OCTA images will be processed to obtain vascular density measurements in this area (mm-1)
Time frame: 24 months
Parafoveal vessel density
OCTA images will be processed to obtain vascular density measurements in this area (mm-1)
Time frame: 24 months
Total Avascular Area
OCTA images will be processed to obtain total avascular area measurements (mm2)
Time frame: 24 months
Foveal Avascular Zone
OCTA images will be processed to obtain foveal avascular zone area measurements (mm2)
Time frame: 24 months
Plan to share: Undecided
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Hospital Clinic of Barcelona