Assessment of Retinal Microcirculation in Patients With Type 1 Diabetes Mellitus

NCT07705321 — Active not recruiting, 100 participants, University of Athens

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Registry	NCT07705321
Status	Active not recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	University of Athens (Other)
Conditions	Diabetes Type 1, Diabetic Retinopathy, Microvascular Circulation, Retinal Microvascular Disease, Diabetic Complications
Interventions	Optical Coherence Tomography Angiography (OCTA) (Diagnostic test)
Dates	start 2025-06-01, primary completion 2026-08-30 (estimated), completion 2026-09-30 (estimated), first posted 2026-07-15, last updated 2026-07-15
Locations	1 site in Greece

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients with Type 1 diabetes mellitus with and without clinically diagnosed diabetic retinopathy		Diagnostic Test: Optical Coherence Tomography Angiography (OCTA)

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.

+Outcome measures

Primary outcomes

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.]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens	Athens	Greece

+Publications

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