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

Bosnia and Herzegovina210 participantsStarted 2024-11-01

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age between 18 and 80 years * diagnosed type 2 diabetes mellitus * literacy, transparent optical media, and visual acuity sufficient to independently complete tasks on the Montreal Cognitive Assesment scale (MoCA) scale (\>0.5), * signed informed consent form allowing participation in the study and use of the data for research and educational purposes. Exclusion Criteria: * illiteracy, * lack of necessary test results, * best corrected visual acuity less than 0.5, * prior anti-VEGF treatment or pars plana vitrectomy (PPV), * proliferative diabetic retinopathy (PDR), * diabetic macular edema involving the center, * non-transparent optical media, * legal incompetence due to psychiatric disorders or intellectual disability, * acute and chronic inflammatory conditions, and * malignant tumors.

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quantitative retinal microcirculation parameters detected on OCTA

Timeframe: Day 1

Trial details

NCT IDNCT07135440

SponsorDr. Sefic Eye Polylcinic and Optical Studio

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus Diabetic Retinopathy Cognitive Dysfunction trials