Assessment of Retinal Microcirculation in Patients With Type 1 Diabetes Mellitus

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Angiopathies Diabetic Complications Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Microvascular Circulation Nutritional and Metabolic Diseases Retinal Diseases Retinal Microvascular Disease Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Athens, 12462, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 15, 2026
Registry last updated: Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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