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NCT07135440Active, not recruiting

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

The Association of Biomarkers Detected by Optical Coherence Tomography Angiography (OCTA) of the Macula With Cognitive Functions in Patients With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 22 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
210 (estimated)
First submitted
1 Aug 2025
Start date
1 Nov 2024
Primary completion date
30 Oct 2025
Lead sponsor
Dr. Sefic Eye Polylcinic and Optical Studio
NCT number
NCT07135440

What you commit to

  • Study type: Observational
  • Planned participants: 210
  • From 1 Nov 2024 to the primary completion date, 30 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • prior anti-VEGF treatment or pars plana vitrectomy (PPV),

Other illness

  • legal incompetence due to psychiatric disorders or intellectual disability,
  • acute and chronic inflammatory conditions, and
  • malignant tumors.

Other

  • illiteracy,
  • lack of necessary test results,
  • best corrected visual acuity less than 0.5,
  • proliferative diabetic retinopathy (PDR),
  • diabetic macular edema involving the center,
  • non-transparent optical media,

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
dr Sefic Eye Polyclinic and Optical Studio
Coordinator of this site? Confirm its status
SarajevoBosnia and HerzegovinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.