Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma

Официальное название

Analysis of the Identification Value and Quadrant Characteristics of Iris OCTA Blood Flow Quantification in Type 2 Diabetic Neovascular Glaucoma

Обзор

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.

Первичные конечные точки

• Iris vessel density [Срок оценки: Enrollment]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Публикации

• Elkholy RE, El Sharkawy AM, Hantash HI, Elaskary EM, Shafik HM, Nawar AE, Almokadem HA. Evaluation of Retinal Microvascular Changes in Juvenile Systemic Lupus Erythematosus Patients Using Optical Coherence Tomography Angiography. Ocul Immunol Inflamm. 2026 Jul 11:1-8. doi: 10.1080/09273948.2026.2690413. Online ahead of print. PMID 42435066
• Zhang G, Chen W, Chen H, Lin J, Cen LP, Xie P, Zheng Y, Ng TK, Brelen ME, Zhang M, Pang CP. Risk factors for diabetic retinopathy, diabetic macular edema, and sight-threatening diabetic retinopathy. Asia Pac J Ophthalmol (Phila). 2024 May-Jun;13(3):100067. doi: 10.1016/j.apjo.2024.100067. Epub 2024 May 13. PMID 38750958
• Qi Z, Si Y, Feng F, Zhu J, Yang X, Wang W, Zhang Y, Cui Y. Analysis of retinal and choroidal characteristics in patients with early diabetic retinopathy using WSS-OCTA. Front Endocrinol (Lausanne). 2023 May 24;14:1184717. doi: 10.3389/fendo.2023.1184717. eCollection 2023. PMID 37293481
• Lidder AK, Paranjpe V, Lauter AJ. Management of Neovascular Glaucoma. Int Ophthalmol Clin. 2023 Oct 1;63(4):167-183. doi: 10.1097/IIO.0000000000000480. Epub 2023 Sep 27. No abstract available. PMID 37755450
• Kalogeropoulos D, Moussa G, Sung VC, Pappa C, Kalogeropoulos C. Neovascular Glaucoma: An Update. Klin Monbl Augenheilkd. 2023 Mar;240(3):305-315. doi: 10.1055/a-1956-9348. Epub 2022 Nov 27. PMID 36436509
• Barth T, Helbig H. [Diabetic retinopathy]. Klin Monbl Augenheilkd. 2021 Oct;238(10):1143-1159. doi: 10.1055/a-1545-9927. Epub 2021 Aug 11. German. PMID 34380155

Идентификаторы

NCT: NCT07722910 · KYLL-2026-06-036

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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