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The Potential of Optical Coherence Tomography Angiography (OCTA) to Detect Early Cognitive Dysfunction in Diabetic Patients

NCT07135440 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 210

Last updated 2025-08-22

No results posted yet for this study

Summary

Diabetic Retinopathy (DR) is one of the most common complications of diabetes, and its association with cognitive dysfunctions is becoming an increasingly frequent research interest. Non-proliferative diabetic retinopathy (NPDR) encompasses early changes at the microvascular level, which can be detected quantitatively and qualitatively through optical coherence tomography angiography (OCTA) well before the first symptoms of this disease appear. Cognitive dysfunction is often unrecognized in the early stages of diabetes. This research will focus on examining the association between OCTA parameters and cognitive functions in patients with NPDR. The aim of this study is to investigate the correlation between OCTA parameters and cognitive functions in patients with NPDR using the Montreal Cognitive Assessment (MoCA) scale to assess cognitive abilities and to establish a connection between OCTA biomarkers and changes in cognitive function. Patients with type 2 diabetes will be included in the study. Patients with proliferations and diabetic macular edema affecting the center and reducing visual acuity will be excluded to minimize error in cognitive function assessment caused by vision impairment. OCTA will be used to analyze microvascular changes in the retina, including capillary density and areas of the avascular zone. At the same time, the MoCA scale will be used to assess cognitive function, focusing on aspects of memory, attention, executive function, and orientation. Data analysis will investigate correlations between OCTA parameters, the presence of diabetic retinopathy-related changes in the eye fundus, as well as the stage of retinopathy and MoCA scale scores, taking into account factors such as diabetes duration, previous diabetes treatment, lipid status, anthropometric parameters, and glycemic control. The results of this research are expected to provide better insight into the early diagnosis of cognitive dysfunctions in patients with diabetes, thereby contributing to the development of targeted interventions.

Conditions

  • Type 2 Diabetes Mellitus Diabetic Retinopathy Cognitive Dysfunction

Interventions

DEVICE

OCT angiography RTVue XR Avanti; Optovue, Inc, Fremont, California, USA

OCTA is a fast, non-invasive, and contactless imaging technique that enables detailed visualization of the retinal microvasculature by tracking erythrocyte movement within blood vessels in real time. It provides layer-by-layer analysis of the retina and choroid without the need for intravenous contrast, significantly reducing patient risk and improving accessibility. Increasing evidence suggests that neurodegenerative and vascular changes precede clinically visible signs of disease, making OCTA a valuable diagnostic tool for early detection of diabetic retinopathy before it can be confirmed through standard fundus examination. The MoCA test includes assessments of executive functions, high-level language abilities, and complex visuospatial tasks, making it suitable for detecting even mild cognitive dysfunction.

Sponsors & Collaborators

  • Dr. Sefic Eye Polylcinic and Optical Studio

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-10-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • Bosnia and Herzegovina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07135440 on ClinicalTrials.gov