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

NCT03422965 | Unknown

• 1 other identifier: OCTAMaratoTV3ICOF
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Perifoveal vessel density

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

  24 months

Secondary Outcomes (3)

• Parafoveal vessel density

  24 months

• Total Avascular Area

  24 months

• Foveal Avascular Zone

  24 months

Study Arms (2)

Type 1 Diabetes Mellitus

ACTIVE COMPARATOR

Cohort of Type 1 DM patients

Diagnostic Test: Optical Coherence Tomography Angiography; Diagnostic Test: Blood test; Diagnostic Test: Urine test

Healthy controls

SHAM COMPARATOR

Cohort of Healthy controls

Diagnostic Test: Optical Coherence Tomography Angiography; Diagnostic Test: Blood test; Diagnostic Test: Urine test

Interventions

Optical Coherence Tomography Angiography DIAGNOSTIC_TEST

Optical Coherence Tomography Angiography images capture.

Healthy controls; Type 1 Diabetes Mellitus

Blood test DIAGNOSTIC_TEST

Blood test, systemic markers

Healthy controls; Type 1 Diabetes Mellitus

Urine test DIAGNOSTIC_TEST

Urine test, systemic markers

Healthy controls; Type 1 Diabetes Mellitus

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 Diabetes Mellitus
• Healthy controls

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Fundació La Marató de TV3: collaborator

Study Sites (2)

Institut Clinic de Oftalmologia (ICOF), Hospital Clínic de Barcelona

Barcelona, 08028, Spain

Location

Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (23)

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• Ishibazawa A, Nagaoka T, Takahashi A, Omae T, Tani T, Sogawa K, Yokota H, Yoshida A. Optical Coherence Tomography Angiography in Diabetic Retinopathy: A Prospective Pilot Study. Am J Ophthalmol. 2015 Jul;160(1):35-44.e1. doi: 10.1016/j.ajo.2015.04.021. Epub 2015 Apr 18.

  PMID: 25896459 BACKGROUND

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• Takase N, Nozaki M, Kato A, Ozeki H, Yoshida M, Ogura Y. ENLARGEMENT OF FOVEAL AVASCULAR ZONE IN DIABETIC EYES EVALUATED BY EN FACE OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2377-83. doi: 10.1097/IAE.0000000000000849.

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• Hwang TS, Gao SS, Liu L, Lauer AK, Bailey ST, Flaxel CJ, Wilson DJ, Huang D, Jia Y. Automated Quantification of Capillary Nonperfusion Using Optical Coherence Tomography Angiography in Diabetic Retinopathy. JAMA Ophthalmol. 2016 Apr;134(4):367-73. doi: 10.1001/jamaophthalmol.2015.5658.

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• Rosines-Fonoll J, Martin-Pinardel R, Marias-Perez S, Suarez-Valero X, Feu-Basilio S, Marin-Martinez S, Bernal-Morales C, Castro-Dominguez R, Mendez-Mourelle A, Oliva C, Vila I, Hernandez T, Vinagre I, Mateu-Salat M, Ortega E, Gimenez M, Zarranz-Ventura J. Optical Coherence Tomography Angiography in Type 1 Diabetes Mellitus. Report 5: Cardiovascular Risk. Biomedicines. 2026 Jan 11;14(1):153. doi: 10.3390/biomedicines14010153.

  PMID: 41595687 DERIVED

• Toha-Dalmau A, Rosines-Fonoll J, Romero E, Mazzanti F, Martin-Pinardel R, Marias-Perez S, Bernal-Morales C, Castro-Dominguez R, Mendez A, Ortega E, Vinagre I, Gimenez M, Vellido A, Zarranz-Ventura J. Machine Learning Prediction of Cardiovascular Risk in Type 1 Diabetes Mellitus Using Radiomic Features from Multimodal Retinal Images. Ophthalmol Sci. 2025 Jul 4;5(6):100874. doi: 10.1016/j.xops.2025.100874. eCollection 2025 Nov-Dec.

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• Sala-Vila A, Vinagre I, Cofan M, Lazaro I, Ale-Chilet A, Barraso M, Hernandez T, Harris WS, Zarranz-Ventura J, Ortega E. Blood omega-3 biomarkers, diabetic retinopathy and retinal vessel status in patients with type 1 diabetes. Eye (Lond). 2025 Jun;39(8):1526-1531. doi: 10.1038/s41433-025-03705-5. Epub 2025 Feb 18.

  PMID: 39966603 DERIVED

• Carrera-Escale L, Benali A, Rathert AC, Martin-Pinardel R, Bernal-Morales C, Ale-Chilet A, Barraso M, Marin-Martinez S, Feu-Basilio S, Rosines-Fonoll J, Hernandez T, Vila I, Castro-Dominguez R, Oliva C, Vinagre I, Ortega E, Gimenez M, Vellido A, Romero E, Zarranz-Ventura J. Radiomics-Based Assessment of OCT Angiography Images for Diabetic Retinopathy Diagnosis. Ophthalmol Sci. 2022 Nov 21;3(2):100259. doi: 10.1016/j.xops.2022.100259. eCollection 2023 Jun.

  PMID: 36578904 DERIVED

• Bernal-Morales C, Ale-Chilet A, Martin-Pinardel R, Barraso M, Hernandez T, Oliva C, Vinagre I, Ortega E, Figueras-Roca M, Sala-Puigdollers A, Gimenez M, Esmatjes E, Adan A, Zarranz-Ventura J. Optical Coherence Tomography Angiography in Type 1 Diabetes Mellitus. Report 4: Glycated Haemoglobin. Diagnostics (Basel). 2021 Aug 25;11(9):1537. doi: 10.3390/diagnostics11091537.

  PMID: 34573883 DERIVED

• Barraso M, Ale-Chilet A, Hernandez T, Oliva C, Vinagre I, Ortega E, Figueras-Roca M, Sala-Puigdollers A, Esquinas C, Esmatjes E, Adan A, Zarranz-Ventura J. Optical Coherence Tomography Angiography in Type 1 Diabetes Mellitus. Report 1: Diabetic Retinopathy. Transl Vis Sci Technol. 2020 Sep 30;9(10):34. doi: 10.1167/tvst.9.10.34. eCollection 2020 Sep.

  PMID: 33062397 DERIVED

• Zarranz-Ventura J, Barraso M, Ale-Chilet A, Hernandez T, Oliva C, Gascon J, Sala-Puigdollers A, Figueras-Roca M, Vinagre I, Ortega E, Esmatjes E, Adan A. 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. BMC Med Imaging. 2019 Nov 21;19(1):91. doi: 10.1186/s12880-019-0391-8.

  PMID: 31752726 DERIVED

MeSH Terms

Conditions

Retinal Diseases; Diabetes Mellitus; Diabetic Retinopathy; Diabetes Mellitus, Type 1

Interventions

Hematologic Tests; Urinalysis

Condition Hierarchy (Ancestors)

Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Javier Zarranz-Ventura, MD PhD FEBO

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FEBO

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 6, 2018
• Study Start: May 8, 2017
• Primary Completion: March 8, 2021
• Study Completion: May 31, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

ES (2)