Perifoveal Vascular Network Assessed by OCT-Angiography in Type I Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Microvascular Changes in the Perifoveal Vascular Network Using Optical Coherence Tomography Angiography (OCT-A) in Type I Diabetes Mellitus

Conditions
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Retinal Disease, Retinal Vascular, Retinal Ischemia, Retinal Ischaemia Due to Type 1 Diabetes Mellitus, Diabetes Mellitus, Diabetic Retinopathy, Diabetes Mellitus, Type 1, Vessels; Retina, Tortuous

Intervention / Treatment
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* Diagnostic Test: Optical Coherence Tomography Angiography
* Diagnostic Test: Blood test
* Diagnostic Test: Urine test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 Diabetes Mellitus Healthy controls Exclusion Criteria: Ocular pathologies other than diabetic retinopathy (i.e. age-related macular degeneration, retinal vein occlusions, uveitis, glaucoma, etc.) Axial length: <-6.00 to >+3.00 diopters Media Opacities Unability to capture OCT images

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Type 1 Diabetes Mellitus<br>Cohort of Type 1 DM patients | Diagnostic Test: Optical Coherence Tomography Angiography<br>* Optical Coherence Tomography Angiography images capture.<br>Diagnostic Test: Blood test<br>* Blood test, systemic markers<br>Diagnostic Test: Urine test<br>* Urine test, systemic markers<br>|
| Sham Comparator: Healthy controls<br>Cohort of Healthy controls | Diagnostic Test: Optical Coherence Tomography Angiography<br>* Optical Coherence Tomography Angiography images capture.<br>Diagnostic Test: Blood test<br>* Blood test, systemic markers<br>Diagnostic Test: Urine test<br>* Urine test, systemic markers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perifoveal vessel density | OCTA images will be processed to obtain vascular density measurements in this area (mm-1) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parafoveal vessel density | OCTA images will be processed to obtain vascular density measurements in this area (mm-1) | 24 months | 
| Total Avascular Area | OCTA images will be processed to obtain total avascular area measurements (mm2) | 24 months | 
| Foveal Avascular Zone | OCTA images will be processed to obtain foveal avascular zone area measurements (mm2) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retina, OCT, Optical Coherence Tomography, Optical Coherence Tomography Angiography, Systemic, Blood, Diabetes Mellitus, Diabetic Retinopathy