AS-OCT Study in Diabetic Retinopathy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04992325

Enrollment

Registered

2021-08-05

Start date

2020-07-01

Completion date

2021-04-30

Last updated

2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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.

Interventions

DIAGNOSTIC_TESTAnterior segment-optical coherence tomography

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The measurements of corneal features in patients with type 2 diabetes mellitus, using anterior segment-optical coherence tomography	twelve months	The parameters analyzed by anterior segment-optical coherence tomography angiography were: total corneal, epithelial and stromal thicknesses

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026