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NCT04992325 Clinical Trial

AS-OCT Study in Diabetic Retinopathy

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04992325
Other study ID # 2021/07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date April 30, 2021

Study information
Verified date July 2021
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 30
Est. completion date April 30, 2021
Est. primary completion date April 25, 2021
Accepts healthy volunteers
Gender All
Age group 50 Years to 60 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Anterior segment-optical coherence tomography
Each subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses.

Locations
Country Name City State
Italy University of Naples "Federico II" Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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