Prospective Geometric Analysis of Ultra-Widefield OCTA Characteristics in Central Serous Chorioretinopathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Choroidal Vascular Fractal Dimension
研究概览
简要总结
By leveraging parameters including fractal dimension and topological index, we constructed a quantitative evaluation framework for ultra-widefield optical coherence tomography angiography (UWF-OCTA) images in patients with central serous chorioretinopathy (CSC), thus overcoming the limitations of conventional qualitative analysis.
详细描述
Central serous chorioretinopathy (CSC) is a macular disorder characterized by choroidal hyperpermeability and serous retinal detachment, with chronicity leading to irreversible visual impairment. Optical coherence tomography angiography (OCTA) allows non-invasive, high-resolution 3D imaging of choroidal microcirculation, but traditional OCTA analysis relies on qualitative assessment, which cannot quantify vascular structural heterogeneity.
This prospective cohort study will enroll 120 subjects, including CSC patients and healthy controls, who will be allocated to acute, chronic, recurrent CSC groups, or healthy control group. Ultra-widefield swept-source OCTA (UWF SS-OCTA) will be used to capture choroidal vascular images. Geometric parameters (fractal dimension, topological index, 3D vascular diameter) will quantify vascular complexity, distribution, and morphology. Strict inclusion/exclusion criteria and matching for age, gender, and refraction will ensure baseline comparability. Follow-up visits will be conducted at 1, 3, 6, and 12 months post-treatment, with repeated OCTA to evaluate dynamic changes in geometric parameters and their associations with treatment response.
This study innovatively integrates geometric methods with UWF-OCTA to establish a quantitative choroidal vascular evaluation framework for CSC. It aims to identify stage-specific vascular characteristics, explore correlations between geometric markers (e.g., dynamic fractal dimension changes) and the efficacy of laser photocoagulation/anti-VEGF therapy, and validate these markers as non-invasive prognostic indicators. UWF-OCTA will enable comprehensive detection of vascular abnormalities, providing evidence for precise CSC management.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 60 years, inclusive;
- •Clinical diagnosis of central serous chorioretinopathy (CSC);
- •Completion of fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) examinations;
- •Completion of ultra-widefield optical coherence tomography angiography (UWF-OCTA) imaging;
- •No prior history of pharmacological or surgical treatment for CSC;
- •Ability and willingness to provide written informed consent.
排除标准
- •Presence of other ophthalmic diseases that may affect retinal or choroidal imaging or analysis, including but not limited to: Significant refractive media opacities interfering with OCTA imaging (e.g., severe cataract, vitreous hemorrhage);
- •Presence of systemic diseases that may affect study outcomes or participant safety;
- •Pregnant or lactating women;
- •History of psychiatric or mental disorders that may impair compliance;
- •Hemorrhagic diathesis or requirement for long-term anticoagulant therapy;
- •History of long-term systemic medication use that may affect choroidal or retinal circulation;
- •Presence of severe and/or uncontrolled comorbid medical conditions, including but not limited to:
- •Uncontrolled diabetes mellitus; Uncontrolled hypertension; Active uncontrolled infection; Chronic obstructive pulmonary disease (COPD) with dyspnea at rest;
- •History of intraocular surgery or intravitreal injection within the past 6 months;
- •High refractive error defined as:
- •Spherical equivalent (SE) < -6.0 diopters or > +3.0 diopters, or Axial length (AL) > 26.0 mm;
- •Any other condition that, in the opinion of the investigator, would make participation unsafe or interfere with protocol adherence.
结局指标
主要结局
Choroidal Vascular Fractal Dimension
时间窗: Baseline, 1 month, 3 months, 6 months, and 12 months
Choroidal vascular fractal dimension quantified from optical coherence tomography angiography (OCTA) images.
次要结局
- Maximum subretinal fluid height(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Subretinal fluid area(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Subretinal fluid volume(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Choroidal vascular branching index(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Choroidal Vascular Connectivity Index(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Mean curvature of choroidal blood vessels(Baseline, 1 month, 3 months, 6 months, and 12 months)
- Mean curvature of retinal blood vessels(Baseline, 1 month, 3 months, 6 months, and 12 months)
研究者
Jin Chen-jin
Director of ophthalmology, Principal Investigator, Clinical Professor
Sun Yat-sen University