AS-OCT Study in Diabetic Retinopathy

Study Overview
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Brief Summary
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This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus

Detailed Description
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To investigate the potential role of anterior segment-optical coherence tomography (AS-OCT) in identifying the corneal changes (in particular in total corneal, epithelial and stromal thicknesses) in patients affected by type 2 diabetes mellitus, without signs of diabetic retinopathy at fundus examination. The AS-OCT could represents a valid early biomarker in these patients.

Official Title
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Anterior Segment- Optical Coherence Tomography as Early Biomarker in Diabetic Retinopathy

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Diagnostic Test: Anterior segment-optical coherence tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age older than 50 years diagnosis of previous type 2 diabetes mellitus absence of signs of diabetic retinopathy absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. absence of significant lens opacities, low-quality OCT and OCT-A images Exclusion Criteria: age younger than 50 years absence of previous diagnosis of type 2 diabetes mellitus presence of signs of diabetic retinopathy presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. presence of significant lens opacities, low-quality OCT and OCT-A images.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 2 diabetes mellitus<br>The patients with previous diagnosis of type 2 diabetes mellitus, without signs of diabetic retinopathy | Diagnostic Test: Anterior segment-optical coherence tomography<br>* Each subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses.<br>|
| Healthy subjects<br>Healthy subjects without actual and previous ocular diseases | Diagnostic Test: Anterior segment-optical coherence tomography<br>* Each subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography | The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses | twelve months |