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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03422965
Enrollment
600
Registered
2018-02-06
Start date
2017-05-08
Completion date
2021-05-31
Last updated
2020-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DIAGNOSTIC_TESTOptical Coherence Tomography Angiography

Optical Coherence Tomography Angiography images capture.

DIAGNOSTIC_TESTBlood test

Blood test, systemic markers

DIAGNOSTIC_TESTUrine test

Urine test, systemic markers

Sponsors

Fundació La Marató de TV3
CollaboratorOTHER
Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Perifoveal vessel density24 monthsOCTA images will be processed to obtain vascular density measurements in this area (mm-1)

Secondary

MeasureTime frameDescription
Parafoveal vessel density24 monthsOCTA images will be processed to obtain vascular density measurements in this area (mm-1)
Total Avascular Area24 monthsOCTA images will be processed to obtain total avascular area measurements (mm2)
Foveal Avascular Zone24 monthsOCTA images will be processed to obtain foveal avascular zone area measurements (mm2)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026