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AS-OCT Study in Diabetic Retinopathy

F

Federico II University

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Diagnostic Test: Anterior segment-optical coherence tomography

Study type

Observational

Funder types

Other

Identifiers

NCT04992325
2021/07

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

50 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Patients with type 2 diabetes mellitus
Description:
The patients with previous diagnosis of type 2 diabetes mellitus, without signs of diabetic retinopathy
Treatment:
Diagnostic Test: Anterior segment-optical coherence tomography
Healthy subjects
Description:
Healthy subjects without actual and previous ocular diseases
Treatment:
Diagnostic Test: Anterior segment-optical coherence tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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