AS-OCT Study in Diabetic Retinopathy
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Diagnostic Test: Anterior segment-optical coherence tomography
- Registration Number
- NCT04992325
- Lead Sponsor
- Federico II University
- Brief Summary
This study evaluates the corneal features using anterior segment - optical coherence tomography in patients affected by type 2 diabetes mellitus
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with type 2 diabetes mellitus Anterior segment-optical coherence tomography The patients with previous diagnosis of type 2 diabetes mellitus, without signs of diabetic retinopathy Healthy subjects Anterior segment-optical coherence tomography Healthy subjects without actual and previous ocular diseases
- Primary Outcome Measures
Name Time Method The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography twelve months The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Naples "Federico II"
🇮🇹Naples, Italy