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Clinical Trials/NCT04992325
NCT04992325
Completed
Not Applicable

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

Federico II University1 site in 1 country30 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Federico II University
Enrollment
30
Locations
1
Primary Endpoint
The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Gilda Cennamo

Principal Investigator

Federico II University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography

Time Frame: twelve months

The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses

Study Sites (1)

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