AS-OCT Study in Diabetic Retinopathy

Completed

• Conditions: Diabetes Mellitus

• 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.

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-04-25
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-29
• Last Update Submitted: 2021-07-29
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05

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

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

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy