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

Hospital Clinic of Barcelona

Status: Unknown

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

Treatments: Diagnostic Test: Urine test; Diagnostic Test: Optical Coherence Tomography Angiography; Diagnostic Test: Blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT03422965

OCTAMaratoTV3ICOF

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Type 1 Diabetes Mellitus

Active Comparator group

Description:

Cohort of Type 1 DM patients

Treatment:

Diagnostic Test: Optical Coherence Tomography Angiography

Diagnostic Test: Blood test

Diagnostic Test: Urine test

Healthy controls

Sham Comparator group

Description:

Cohort of Healthy controls

Treatment:

Diagnostic Test: Optical Coherence Tomography Angiography

Diagnostic Test: Blood test

Diagnostic Test: Urine test