Diabetes Type 1, Diabetic Complications, Diabetic Retinopathy, Microvascular Circulation, Retinal Microvascular Disease
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTOptical Coherence Tomography Angiography (OCTA)
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.
Sponsors
University of Athens
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 years or older. 2. Diagnosis of Type 1 diabetes mellitus (T1DM) according to the American Diabetes Association (ADA) criteria. 3. Ability and willingness to provide written informed consent.
Exclusion criteria
1. Active uveitis or other intraocular inflammatory disease. 2. Uncontrolled glaucoma 3. High myopia (spherical equivalent refractive error \>5.0 diopters) 4. History of ocular trauma. 5. History of intraocular surgery within the previous 6 months.
Design outcomes
Primary
| Measure | 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. |
Countries
Greece
Outcome results
None listed