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

NCT ID: NCT07347119

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-18
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Central Serous Chorioretinopathy (CSC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute Central Serous Chorioretinopathy

Clinically, serous retinal detachment (SRD) can be detected via fundus examination and optical coherence tomography (OCT), along with focal or multifocal retinal pigment epithelium (RPE) changes confined to small pigment epithelial detachment (PED) lesions. Fundus fluorescein angiography (FFA) demonstrates RPE leakage. SRD typically resolves within 3-4 months, and in most cases, no long-term symptoms persist except for color discrimination deficits in some patients.

No interventions assigned to this group

Chronic Central Serous Chorioretinopathy

When the disease course exceeds 4-6 months, obvious multifocal atrophic retinal pigment epithelium (RPE) changes, multifocal leakage, and extensive RPE atrophy can be observed. Fundus autofluorescence (FAF) shows hypofluorescence in the RPE-damaged areas.

No interventions assigned to this group

Recurrent Central Serous Chorioretinopathy

The patient has a history of one or more previous episodes, during which the symptoms completely resolved or significantly improved, and optical coherence tomography (OCT) examination showed complete absorption of subretinal fluid, with reattachment of the neurosensory retina. After complete remission of the first (or previous) episode (an interval of at least 3-6 months is generally considered), the patient develops typical symptoms of central serous chorioretinopathy (CSC) again, accompanied by objective evidence of the acute or chronic phase, such as changes detected by OCT or fundus fluorescein angiography (FFA).

No interventions assigned to this group

Control Group

Healthy control subjects without any local or systemic diseases

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jin Chen-jin

Director of ophthalmology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chenjin Jin, PH.D

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510060

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Rongtian Chen

Role: CONTACT

376126340@qq.com

16619724130

Facility Contacts

Rongtian Chen

Role: primary

376126340@qq.com

16619724130

Other Identifiers

2025KYPJ135

Identifier Type: -

Identifier Source: org_study_id