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NCT Number: NCT07347119

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location contact

Chenjin Jin, PH.D

PRINCIPAL_INVESTIGATOR

Rongtian Chen

CONTACT

[email protected]

16619724130

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Choroidal Vascular Fractal Dimension

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    Choroidal vascular fractal dimension quantified from optical coherence tomography angiography (OCTA) images.

Secondary outcomes

  1. Maximum subretinal fluid height

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    The maximum height of subretinal fluid measured in micrometers (μm) on optical coherence tomography angiography (OCTA) images.

  2. Subretinal fluid area

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    The basal area of subretinal fluid measured in square millimeters (mm²) on optical coherence tomography angiography (OCTA) images.

  3. Subretinal fluid volume

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    The volume of subretinal fluid measured in cubic millimeters (mm³) on optical coherence tomography angiography (OCTA) images.

  4. Choroidal vascular branching index

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    The branching index of choroidal blood vessels quantified from optical coherence tomography angiography (OCTA) images.

  5. Choroidal Vascular Connectivity Index

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    The connectivity index of choroidal blood vessels quantified from optical coherence tomography angiography (OCTA) images.

  6. Mean curvature of choroidal blood vessels

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    The mean curvature of choroidal blood vessels quantified from optical coherence tomography angiography (OCTA) images.

  7. Mean curvature of retinal blood vessels

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months

    The mean curvature of retinal blood vessels quantified from optical coherence tomography angiography (OCTA) images.

Study contacts

Contact information is provided by the study sponsor or research team.

Rongtian Chen

CONTACT

[email protected]

16619724130

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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