Assessment of Retinal Microcirculation in Patients With Type 1 Diabetes Mellitus

NCT07705321 | Active Not Recruiting

• 1 other identifier: 322/29-04-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Type 1; Diabetic Retinopathy; Microvascular Circulation; Retinal Microvascular Disease; Diabetic Complications

Outcome Measures

Primary Outcomes (1)

• Quantitative assessment of retinal vessel density measured by optical coherence tomography angiography (OCTA).

  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.

Study Arms (1)

Patients with Type 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy

Diagnostic Test: Optical Coherence Tomography Angiography (OCTA)

Interventions

Optical Coherence Tomography Angiography (OCTA) DIAGNOSTIC_TEST

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.

Patients with Type 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

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

Athens, 12462, Greece

Location

Related Publications (1)

• Cutruzzola A, Carnevali A, Gatti V, Latella G, Lamonica L, Oliverio F, Borelli M, Parise M, Di Molfetta S, Scorcia V, Irace C, Gnasso A. Continuous Glucose Monitoring-Derived Metrics and Capillary Vessel Density in Subjects with Type 1 Diabetes without Diabetic Retinopathy. J Diabetes Res. 2023 Apr 15;2023:9516059. doi: 10.1155/2023/9516059. eCollection 2023.

  PMID: 37096234 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Retinopathy; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Ophthalmology, 2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)