Assessment of Retinal Microcirculation in Patients With Type 1 Diabetes Mellitus

July 12, 2026 updated by: Irini Chatziralli, University of Athens
Type 1 diabetes mellitus (T1DM) is associated with an increased lifetime risk of developing diabetic retinopathy, a leading cause of visual impairment among working-age adults worldwide. Retinal assessment plays a pivotal role in the management of patients with T1DM, as the retina provides a unique, non-invasive window into the body's microvascular circulation. Early detection of retinal abnormalities is essential because structural and microvascular changes may develop years before the onset of vision-threatening diabetic retinopathy or visual symptoms. Contemporary retinal imaging techniques, enable the quantitative evaluation of retinal microvasculature allowing the identification of subclinical retinal damage.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

  • Greece
      • Athens, Greece, 12462
        • 2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with Type 1 diabetes mellitus, with or without clinically diagnosed diabetic retinopathy, recruited from the 2nd Department Ophthalmology outpatient clinics with and without diabetic retinopathy.

Description

Inclusion Criteria:

  1. Adults aged 18 years or older.
  2. Diagnosis of Type 1 diabetes mellitus (T1DM) according to the American Diabetes Association (ADA) criteria.
  3. Ability and willingness to provide written informed consent.

Exclusion Criteria:

  1. Active uveitis or other intraocular inflammatory disease.
  2. Uncontrolled glaucoma
  3. High myopia (spherical equivalent refractive error >5.0 diopters)
  4. History of ocular trauma.
  5. History of intraocular surgery within the previous 6 months.

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 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy
Diagnostic test: Optical Coherence Tomography Angiography (OCTA)
A non-invasive retinal imaging technique that provides high-resolution visualization and quantitative assessment of the retinal and choroidal microvasculature, including vessel density and the foveal avascular zone, without the use of intravenous dye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA).
Time Frame: Vessel density will be assessed at baseline using OCTA. This is a cross-sectional study; no follow-up assessments will be performed. Participants will be evaluated at a single study visit and classified according to the stage of diabetic retinopathy.
Vessel density will be assessed at baseline using OCTA. This is a cross-sectional study; no follow-up assessments will be performed. Participants will be evaluated at a single study visit and classified according to the stage of diabetic retinopathy.

Collaborators and Investigators

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

Sponsor

University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 322/29-04-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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