AS-OCT Study in Diabetic Retinopathy

NCT ID: NCT04992325

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with type 2 diabetes mellitus

The patients with previous diagnosis of type 2 diabetes mellitus, without signs of diabetic retinopathy

Anterior segment-optical coherence tomography

Intervention Type DIAGNOSTIC_TEST

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

Anterior segment-optical coherence tomography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anterior segment-optical coherence tomography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federico II University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gilda Cennamo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gilda Cennamo

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Naples "Federico II"

Naples, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021/07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

OCT Biomarkers for Diabetic Retinopathy
NCT02330042 ACTIVE_NOT_RECRUITING