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NCT Number: NCT04992325

AS-OCT Study in Diabetic Retinopathy

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anterior segment-optical coherence tomography

Diagnostic Test

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2021
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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