Evaluation of microvascular changes in the perifoveal vascular network using optical coherence tomography angiography (OCTA) in type I diabetes mellitus: a large scale prospective trial.


Journal

BMC medical imaging
ISSN: 1471-2342
Titre abrégé: BMC Med Imaging
Pays: England
ID NLM: 100968553

Informations de publication

Date de publication:
21 11 2019
Historique:
received: 02 08 2019
accepted: 25 10 2019
entrez: 23 11 2019
pubmed: 23 11 2019
medline: 10 5 2020
Statut: epublish

Résumé

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 (OCTA) is a newly developed, non-invasive, retinal imaging technique that permits adequate delineation of the perifoveal vascular network. It allows the detection of paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (FAZ), representing an excellent tool for assessment of DR. The relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still needs to be elucidated. Prospective, consecutive, large-scale OCTA study. A complete ocular examination including a comprehensive series of OCTA images of different scan sizes captured with 2 OCT devices (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA, USA, and Triton Deep Range Imaging OCT, Topcon Corp, Topcon, Japan) will be obtained as part of the yearly routine follow up visits in type 1 DM patients seen in the Diabetes Unit of the Endocrinology department which give written informed consent to participate in the project. The aim of this study is to investigate the relationship between OCTA-derived parameters and systemic factors, as metabolic control (Hb1Ac, lipid profile, cholesterol, etc), and other relevant clinical factors as demographics or duration of the disease. This study is directed to investigate the relationship between the status of the perifoveal vascular network and systemic markers of the disease, and in particular to study 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 by OCTA could lead to modifications in the pharmacological management of type 1 diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs. ClinicalTrials.gov, trial number NCT03422965.

Sections du résumé

BACKGROUND
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 (OCTA) is a newly developed, non-invasive, retinal imaging technique that permits adequate delineation of the perifoveal vascular network. It allows the detection of paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (FAZ), representing an excellent tool for assessment of DR. The relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still needs to be elucidated.
METHODS
Prospective, consecutive, large-scale OCTA study. A complete ocular examination including a comprehensive series of OCTA images of different scan sizes captured with 2 OCT devices (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA, USA, and Triton Deep Range Imaging OCT, Topcon Corp, Topcon, Japan) will be obtained as part of the yearly routine follow up visits in type 1 DM patients seen in the Diabetes Unit of the Endocrinology department which give written informed consent to participate in the project. The aim of this study is to investigate the relationship between OCTA-derived parameters and systemic factors, as metabolic control (Hb1Ac, lipid profile, cholesterol, etc), and other relevant clinical factors as demographics or duration of the disease.
DISCUSSION
This study is directed to investigate the relationship between the status of the perifoveal vascular network and systemic markers of the disease, and in particular to study 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 by OCTA could lead to modifications in the pharmacological management of type 1 diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs.
TRIAL REGISTRATION
ClinicalTrials.gov, trial number NCT03422965.

Identifiants

pubmed: 31752726
doi: 10.1186/s12880-019-0391-8
pii: 10.1186/s12880-019-0391-8
pmc: PMC6873669
doi:

Substances chimiques

Glycated Hemoglobin A 0
hemoglobin A1c protein, human 0
Cholesterol 97C5T2UQ7J

Banques de données

ClinicalTrials.gov
['NCT03422965']

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

91

Références

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Auteurs

Javier Zarranz-Ventura (J)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain. jzarranz@hotmail.com.
Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. jzarranz@hotmail.com.

Marina Barraso (M)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.

Anibal Alé-Chilet (A)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.

Teresa Hernandez (T)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.

Cristian Oliva (C)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.

Jesus Gascón (J)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.

Anna Sala-Puigdollers (A)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.
Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

Marc Figueras-Roca (M)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.
Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

Irene Vinagre (I)

Diabetes Unit, Institut Clínic de Malalties Digestives i Metaboliques (ICMDM), Hospital Clinic de Barcelona, Barcelona, Spain.

Emilio Ortega (E)

Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Diabetes Unit, Institut Clínic de Malalties Digestives i Metaboliques (ICMDM), Hospital Clinic de Barcelona, Barcelona, Spain.

Enric Esmatjes (E)

Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Diabetes Unit, Institut Clínic de Malalties Digestives i Metaboliques (ICMDM), Hospital Clinic de Barcelona, Barcelona, Spain.

Alfredo Adan (A)

Institut Clínic d'Oftalmología (ICOF), Hospital Clinic de Barcelona, C/ Sabino Arana 1, 08028, Barcelona, Spain.
Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

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Classifications MeSH