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

Not Applicable

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus; Diabetic Retinopathy; Vessels; Retina, Tortuous; Retinal Vascular; Retinal Disease; Retinal Ischemia; Retinal Ischaemia Due to Type 1 Diabetes Mellitus
• Interventions: Diagnostic Test: Optical Coherence Tomography Angiography; Diagnostic Test: Blood test; Diagnostic Test: Urine test

• Registration Number: NCT03422965
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-05-08
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-30
• Study First Posted: 2018-02-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29
• Primary Completion: 2021-03-08
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type 1 Diabetes Mellitus	Blood test	Cohort of Type 1 DM patients
Healthy controls	Optical Coherence Tomography Angiography	Cohort of Healthy controls
Type 1 Diabetes Mellitus	Optical Coherence Tomography Angiography	Cohort of Type 1 DM patients
Healthy controls	Urine test	Cohort of Healthy controls
Type 1 Diabetes Mellitus	Urine test	Cohort of Type 1 DM patients
Healthy controls	Blood test	Cohort of Healthy controls

Primary Outcome Measures

Name	Time	Method
Perifoveal vessel density	24 months	OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain