跳至主要内容
临床试验/NCT07135440
NCT07135440进行中(未招募)不适用

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

Dr. Sefic Eye Polylcinic and Optical Studio1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
210
试验地点
1
主要终点
Quantitative retinal microcirculation parameters detected on OCTA

研究概览

简要总结

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.

详细描述

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 four zones: superficial retinal plexus, deep retinal plexus, outer retina, and choriocapillaris. OCTA enables monitoring of retinal vascular changes over time and allows early detection of microcirculatory abnormalities.

Cognition is the process by which the human brain receives information from the external environment, processes it, and transforms it into internal psychological activities for acquiring or applying knowledge. It includes memory, language, visuospatial skills, executive function, calculation, comprehension, and judgment. Various cognitive function tests have been developed through years of research. The most commonly used screening test for general cognitive function is the Mini-Mental State Examination (MMSE), while a more recent and sensitive tool is the Montreal Cognitive Assessment (MoCA). 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. Although these tests can assess a patient's cognitive level, they cannot confirm the presence of cerebral microvascular disease.

Numerous studies suggest a link between diabetes mellitus and cognitive impairment. While cognitive decline is not specific to diabetes, it is now recognized as a complication of the disease. In studies involving older populations, patients with diabetes demonstrated a higher risk of developing Alzheimer's disease and other forms of dementia. Since diabetes affects the entire vascular system, it is assumed that changes in the retinal microvasculature may reflect the general vascular condition of the body, including changes in the brain. Studies have shown that patients with advanced stages of DR often exhibit reduced cerebral blood flow, further contributing to cognitive decline.

Research also suggests that early interventional treatments, such as improved glycemic control and therapies aimed at enhancing vascular function, could reduce the risk of cognitive deterioration. There is growing evidence that changes in the retinal microvascular structure may reflect similar alterations in cerebral vascular structures, given that the retina and brain share common embryological and anatomical characteristics.

This study differs from previous ones as it focuses exclusively on the early stages of NPDR, including patients with diabetes who show no detectable changes on fundoscopy. This minimizes the risk of errors on the MoCA scale, since patients with reduced visual acuity due to macular edema or proliferative changes may score falsely low, leading to inaccurate assessments of their cognitive function.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Quantitative retinal microcirculation parameters detected on OCTA

时间窗: Day 1

Retinal vessel density will be assessed using Optical Coherence Tomography Angiography (OCTA), focusing on specific retinal layers such as the superficial and deep capillary plexus. Quantitative analysis will include vessel density (%) and foveal avascular zone (FAZ) parameters. These measurements aim to identify microvascular changes potentially associated with cognitive function in patients with type 2 diabetes mellitus.

次要结局

  • MoCA Score for Cognitive Function Assessment(Day 1)

研究者

发起方
Dr. Sefic Eye Polylcinic and Optical Studio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aida Pidro Gadzo

General hospital "prim.dr.Abudlah Nakas" and Dr. Sefic Eye Polyclinic and Optical Studio

Dr. Sefic Eye Polylcinic and Optical Studio

研究点 (1)

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