- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347119
Prospective Geometric Analysis of Ultra-Widefield OCTA Characteristics in Central Serous Chorioretinopathy Patients
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rongtian Chen
- Phone Number: 16619724130
- Email: 376126340@qq.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Zhongshan Ophthalmic Center, Sun Yat-sen University
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Contact:
- Rongtian Chen
- Phone Number: 16619724130
- Email: 376126340@qq.com
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Principal Investigator:
- Chenjin Jin, PH.D
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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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).
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Control Group
Healthy control subjects without any local or systemic diseases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Choroidal Vascular Fractal Dimension
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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Choroidal vascular fractal dimension quantified from optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maximum subretinal fluid height
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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The maximum height of subretinal fluid measured in micrometers (μm) on optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Subretinal fluid area
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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The basal area of subretinal fluid measured in square millimeters (mm²) on optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Subretinal fluid volume
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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The volume of subretinal fluid measured in cubic millimeters (mm³) on optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Choroidal vascular branching index
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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The branching index of choroidal blood vessels quantified from optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Choroidal Vascular Connectivity Index
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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The connectivity index of choroidal blood vessels quantified from optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Mean curvature of choroidal blood vessels
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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The mean curvature of choroidal blood vessels quantified from optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Mean curvature of retinal blood vessels
Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months
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The mean curvature of retinal blood vessels quantified from optical coherence tomography angiography (OCTA) images.
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Baseline, 1 month, 3 months, 6 months, and 12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chenjin Jin, PH.D, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510060
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025KYPJ135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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