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Clinical Trials/NCT03422965
NCT03422965UnknownNot Applicable

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

Hospital Clinic of Barcelona4 sites in 1 country600 target enrollmentStarted: May 8, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
600
Locations
4
Primary Endpoint
Perifoveal vessel density

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Perifoveal vessel density

Time Frame: 24 months

OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

Secondary Outcomes

  • Parafoveal vessel density(24 months)
  • Total Avascular Area(24 months)
  • Foveal Avascular Zone(24 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Javier Zarranz-Ventura

MD, PhD, FEBO

Hospital Clinic of Barcelona

Study Sites (4)

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