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Type 1 diabetes mellitus (T1DM) is associated with an increased lifetime risk of developing diabetic retinopathy, a leading cause of visual impairment among working-age adults worldwide. Retinal assessment plays a pivotal role in the management of patients with T1DM, as the retina provides a unique, non-invasive window into the body's microvascular circulation. Early detection of retinal abnormalities is essential because structural and microvascular changes may develop years before the onset of vision-threatening diabetic retinopathy or visual symptoms. Contemporary retinal imaging techniques, enable the quantitative evaluation of retinal microvasculature allowing the identification of subclinical retinal damage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Type 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography Angiography (OCTA) | Diagnostic Test | A non-invasive retinal imaging technique that provides high-resolution visualization and quantitative assessment of the retinal and choroidal microvasculature, including vessel density and the foveal avascular zone, without the use of intravenous dye. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA). | Vessel density will be assessed at baseline using OCTA. This is a cross-sectional study; no follow-up assessments will be performed. Participants will be evaluated at a single study visit and classified according to the stage of diabetic retinopathy. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with Type 1 diabetes mellitus, with or without clinically diagnosed diabetic retinopathy, recruited from the 2nd Department Ophthalmology outpatient clinics with and without diabetic retinopathy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens | Athens | 12462 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37096234 | Background | Cutruzzola A, Carnevali A, Gatti V, Latella G, Lamonica L, Oliverio F, Borelli M, Parise M, Di Molfetta S, Scorcia V, Irace C, Gnasso A. Continuous Glucose Monitoring-Derived Metrics and Capillary Vessel Density in Subjects with Type 1 Diabetes without Diabetic Retinopathy. J Diabetes Res. 2023 Apr 15;2023:9516059. doi: 10.1155/2023/9516059. eCollection 2023. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003930 | Diabetic Retinopathy |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |