Clinical trial NCT03422965: Perifoveal Vascular Network Assessed by OCT-Angiography in Type I Diabetes Mellitus
Official title: Evaluation of Microvascular Changes in the Perifoveal Vascular Network Using Optical Coherence Tomography Angiography (OCT-A) in Type I Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Vascular
Retinal Disease
Retinal Ischemia
Retinal Ischaemia Due to Type 1 Diabetes Mellitus
Diabetes Mellitus
Diabetic Retinopathy
Diabetes Mellitus, Type 1
Vessels; Retina, Tortuous
Keywords: Retina
OCT
Optical Coherence Tomography
Optical Coherence Tomography Angiography
Systemic
Blood
Diabetes Mellitus
Diabetic Retinopathy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundació La Marató de TV3
First posted: 2018-02-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Perifoveal vessel density
timeFrame: 24 months
Secondary outcomes:
measure: Parafoveal vessel density
timeFrame: 24 months
measure: Total Avascular Area
timeFrame: 24 months
measure: Foveal Avascular Zone
timeFrame: 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Javier Zarranz-Ventura, MD PhD FEBO
role: PRINCIPAL_INVESTIGATOR
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