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| Name | Class |
|---|---|
| Fundació La Marató de TV3 | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 Diabetes Mellitus | Active Comparator | Cohort of Type 1 DM patients |
|
| Healthy controls | Sham Comparator | Cohort of Healthy controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography Angiography | Diagnostic Test | Optical Coherence Tomography Angiography images capture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perifoveal vessel density | OCTA images will be processed to obtain vascular density measurements in this area (mm-1) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parafoveal vessel density | OCTA images will be processed to obtain vascular density measurements in this area (mm-1) | 24 months |
| Total Avascular Area | OCTA images will be processed to obtain total avascular area measurements (mm2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Zarranz-Ventura, MD PhD FEBO | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Clinic de Oftalmologia (ICOF), Hospital ClÃnic de Barcelona | Barcelona | 08028 | Spain | |||
| Diabetes Unit, Institut Clinic de Malalties Digestives i Métaboliques (ICMDM), Hospital ClÃnic de Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25541604 | Background | Song SJ, Wong TY. Current concepts in diabetic retinopathy. Diabetes Metab J. 2014 Dec;38(6):416-25. doi: 10.4093/dmj.2014.38.6.416. | |
| 6367724 | Background | Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin epidemiologic study of diabetic retinopathy. II. Prevalence and risk of diabetic retinopathy when age at diagnosis is less than 30 years. Arch Ophthalmol. 1984 Apr;102(4):520-6. doi: 10.1001/archopht.1984.01040030398010. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 4, 2022 | |
| Reset | Jun 30, 2023 |
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| Blood test | Diagnostic Test | Blood test, systemic markers |
|
| Urine test | Diagnostic Test | Urine test, systemic markers |
|
| 24 months |
| Foveal Avascular Zone | OCTA images will be processed to obtain foveal avascular zone area measurements (mm2) | 24 months |
| Barcelona |
| 08036 |
| Spain |
| 19265246 | Background | Shah CA. Diabetic retinopathy: A comprehensive review. Indian J Med Sci. 2008 Dec;62(12):500-19. |
| 26904690 | Background | Roser P, Kalscheuer H, Groener JB, Lehnhoff D, Klein R, Auffarth GU, Nawroth PP, Schuett F, Rudofsky G. Diabetic Retinopathy Screening Ratio Is Improved When Using a Digital, Nonmydriatic Fundus Camera Onsite in a Diabetes Outpatient Clinic. J Diabetes Res. 2016;2016:4101890. doi: 10.1155/2016/4101890. Epub 2016 Jan 21. |
| 23689796 | Background | Looker HC, Nyangoma SO, Cromie DT, Olson JA, Leese GP, Philip S, Black MW, Doig J, Lee N, Briggs A, Hothersall EJ, Morris AD, Lindsay RS, McKnight JA, Pearson DW, Sattar NA, Wild SH, McKeigue P, Colhoun HM; Scottish Diabetes Research Network (SDRN) Epidemiology Group and the Scottish Diabetic Retinopathy Collaborative. Predicted impact of extending the screening interval for diabetic retinopathy: the Scottish Diabetic Retinopathy Screening programme. Diabetologia. 2013 Aug;56(8):1716-25. doi: 10.1007/s00125-013-2928-7. Epub 2013 May 21. |
| 25759962 | Background | Zimmer-Galler IE, Kimura AE, Gupta S. Diabetic retinopathy screening and the use of telemedicine. Curr Opin Ophthalmol. 2015 May;26(3):167-72. doi: 10.1097/ICU.0000000000000142. |
| 5684307 | Background | Gass JD. A fluorescein angiographic study of macular dysfunction secondary to retinal vascular disease. IV. Diabetic retinal angiopathy. Arch Ophthalmol. 1968 Nov;80(5):583-91. doi: 10.1001/archopht.1968.00980050585004. No abstract available. |
| 8960844 | Background | Fioretto P, Mauer M, Brocco E, Velussi M, Frigato F, Muollo B, Sambataro M, Abaterusso C, Baggio B, Crepaldi G, Nosadini R. Patterns of renal injury in NIDDM patients with microalbuminuria. Diabetologia. 1996 Dec;39(12):1569-76. doi: 10.1007/s001250050616. |
| 1891225 | Background | Kwiterovich KA, Maguire MG, Murphy RP, Schachat AP, Bressler NM, Bressler SB, Fine SL. Frequency of adverse systemic reactions after fluorescein angiography. Results of a prospective study. Ophthalmology. 1991 Jul;98(7):1139-42. doi: 10.1016/s0161-6420(91)32165-1. |
| 19395034 | Background | Yeung L, Lima VC, Garcia P, Landa G, Rosen RB. Correlation between spectral domain optical coherence tomography findings and fluorescein angiography patterns in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1158-67. doi: 10.1016/j.ophtha.2008.12.063. Epub 2009 Apr 23. |
| 22418228 | Background | Jia Y, Tan O, Tokayer J, Potsaid B, Wang Y, Liu JJ, Kraus MF, Subhash H, Fujimoto JG, Hornegger J, Huang D. Split-spectrum amplitude-decorrelation angiography with optical coherence tomography. Opt Express. 2012 Feb 13;20(4):4710-25. doi: 10.1364/OE.20.004710. |
| 25897021 | Background | Jia Y, Bailey ST, Hwang TS, McClintic SM, Gao SS, Pennesi ME, Flaxel CJ, Lauer AK, Wilson DJ, Hornegger J, Fujimoto JG, Huang D. Quantitative optical coherence tomography angiography of vascular abnormalities in the living human eye. Proc Natl Acad Sci U S A. 2015 May 5;112(18):E2395-402. doi: 10.1073/pnas.1500185112. Epub 2015 Apr 20. |
| 25896459 | Background | 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. |
| 26469537 | Background | de Carlo TE, Chin AT, Bonini Filho MA, Adhi M, Branchini L, Salz DA, Baumal CR, Crawford C, Reichel E, Witkin AJ, Duker JS, Waheed NK. DETECTION OF MICROVASCULAR CHANGES IN EYES OF PATIENTS WITH DIABETES BUT NOT CLINICAL DIABETIC RETINOPATHY USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2364-70. doi: 10.1097/IAE.0000000000000882. |
| 26457396 | Background | 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. |
| 26795548 | Background | 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. |
| 41595687 | Derived | 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. |
| 40893617 | 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. |
| 39966603 | Derived | 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. |
| 36578904 | 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. |
| 34573883 | 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. |
| 33062397 | 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. |
| 31752726 | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 4, 2022 | Jun 30, 2023 |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D016482 | Urinalysis |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D019963 | Clinical Chemistry Tests |
| D003950 | Diagnostic Techniques, Urological |
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