AS-OCT Study in Diabetic Retinopathy

July 29, 2021 updated by: Gilda Cennamo, Federico II University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80100
        • University of Naples "Federico II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 50 years with previous diagnosis of type 2 diabetes mellitus without signs of diabetic retinopathy.

The participans did not present other ophthalmological diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

April 25, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

July 25, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

August 5, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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