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

July 27, 2020 updated by: Javier Zarranz-Ventura, Hospital Clinic of Barcelona

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona
      • Barcelona, Spain, 08036
        • Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

Fundació La Marató de TV3

Investigators

  • Principal Investigator: Javier Zarranz-Ventura, MD PhD FEBO, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2017

Primary Completion (Anticipated)

March 8, 2021

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCTAMaratoTV3ICOF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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