Status:
ACTIVE_NOT_RECRUITING
The Potential of Optical Coherence Tomography Angiography (OCTA) to Detect Early Cognitive Dysfunction in Diabetic Patients
Lead Sponsor:
Dr. Sefic Eye Polylcinic and Optical Studio
Conditions:
Type 2 Diabetes Mellitus Diabetic Retinopathy Cognitive Dysfunction
Eligibility:
All Genders
18-80 years
Brief 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...
Detailed Description
OCTA represents a potential alternative for early detection of vascular abnormalities. OCTA algorithms generate an image, most commonly sized 3x3 mm or 6x6 mm, which is conventionally segmented into f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT07135440
Start Date
November 1 2024
End Date
December 31 2025
Last Update
August 22 2025
Active Locations (1)
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1
dr Sefic Eye Polyclinic and Optical Studio
Sarajevo, Bosnia and Herzegovina, 71000