Menu
Not yet recruiting NCT07347119

Prospective Geometric Analysis of Ultra-Widefield OCTA Characteristics in Central Serous Chorioretinopathy Patients

Observational Central Serous Chorioretinopathy (CSC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Central Serous Chorioretinopathy (CSC). Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Primary outcome measures

  • Choroidal Vascular Fractal Dimension [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
Secondary outcome measures (7)
  • Maximum subretinal fluid height [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
  • Subretinal fluid area [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
  • Subretinal fluid volume [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
  • Choroidal vascular branching index [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
  • Choroidal Vascular Connectivity Index [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
  • Mean curvature of choroidal blood vessels [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]
  • Mean curvature of retinal blood vessels [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

-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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07347119 · 2025KYPJ135

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗