NCT07722910招募中不适用
Analysis of the Identification Value and Quadrant Characteristics of Iris OCTA Blood Flow Quantification in Type 2 Diabetic Neovascular Glaucoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Iris vessel density
研究概览
简要总结
The goal of this observational study is to quantify iris blood flow via non-invasive eye scanning for evaluating ocular lesions in adults aged 18 years and older, including healthy volunteers, patients with type 2 diabetes mellitus (T2DM) without fundus lesions, T2DM patients with diabetic retinopathy (DR), and T2DM patients complicated with both DR and neovascular glaucoma (NVG). The main questions it aims to answer are:
- Does iris blood flow fraction at six pupillary quadrants differ significantly among people with different stages of type 2 diabetic eye complications?
- Are there quadrant-specific and gender-based differences in iris microcirculation changes caused by diabetic eye diseases? If there is a comparison group: Researchers will compare iris blood flow data from four groups (healthy controls, T2DM without DR, T2DM with DR, T2DM with DR + NVG) to see how iris blood circulation changes as diabetic eye conditions get worse, and test whether iris blood flow indicators can help identify patients with neovascular glaucoma.
Participants will complete the following tasks:
- Provide basic personal information, past medical history and recent laboratory test results from their routine medical records;
- Receive a painless, non-invasive iris OCTA eye scan to capture iris blood flow images at six quadrants around the pupil.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years of age, regardless of gender, with or without type 2 diabetes mellitus and its associated ocular complications; clear consciousness, capable of cooperating with iris OCTA examination (able to stabilize the head to guarantee successful acquisition and interpretable images).
- •Voluntary participation in this study with signed written informed consent.
- •No history of intraocular surgery in the examined eye (including cataract surgery, glaucoma filtering surgery, retinal surgery, etc.).
- •General physical conditions: No acute disease episodes within the recent 3 months (such as acute myocardial infarction, stroke, diabetic ketoacidosis); no severe liver or renal dysfunction (ALT and AST ≤ 2 times the upper limit of normal, serum creatinine ≤ 133 μmol/L).
排除标准
- •The studied eye suffers from other ocular diseases that may interfere with examination results apart from the disorders specified in Criterion 1 of the inclusion criteria (e.g., uveitis, retinal vein occlusion, high myopia-related fundus lesions, etc.); invasive ocular treatments were administered to the studied eye within the past 6 months (e.g., retinal laser photocoagulation, intravitreal injection, etc.).
- •Subjects complicated with type 1 diabetes mellitus, gestational diabetes mellitus or other specific types of diabetes mellitus; those with autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) or hematological diseases (e.g., leukemia, aplastic anemia); individuals who have taken medications affecting ocular microcirculation (e.g., alprostadil, nitrates) within the past 3 months and are unable to discontinue such drugs.
- •Subjects with severe head tremors and inability to maintain a fixed posture during examination, resulting in substandard OCTA image quality (interpretable area < 80%); those with mental disorders or cognitive dysfunction who fail to understand and cooperate with the examination procedures.
研究组 & 干预措施
NDR
Patients with type 2 diabetes but without diabetic retinopathy
DR+NVG
Patients with type 2 diabetic retinopathy and neovascular glaucoma
Control
Patients without type 2 diabetes
DR
Patients with type 2 diabetic retinopathy
结局指标
主要结局
Iris vessel density
时间窗: Enrollment
Iris vessel density measured by Optical Coherence Tomography Angiography(OCTA)
次要结局
未报告次要终点
研究者
YutingZhang
Principal Investigator
Qilu Hospital of Shandong University
研究点 (1)
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