Central Serous Chorioretinopathy
Conditions
Keywords
central serous chorioretinopathy, Bifidobacterium genus, the gut dysbiosis
Brief summary
To investigate the potential association between gut microbiota and central serous chorioretinopathy (CSC), clinical observations have indicated that patients with CSC frequently present with chronic gastrointestinal symptoms. This observation has led to the hypothesis that CSC may be associated with gut dysbiosis. The genus Bifidobacterium is widely recognized as a beneficial component of the gut microbiota, and multiple well-established Bifidobacterium supplements are commercially available. To explore this potential association, fecal samples will be collected from both CSC patients and healthy controls. Whole-metagenome shotgun sequencing will be performed to compare gut microbial compositions between the two groups and to determine whether significant differences exist. In addition, CSC patients will be randomly assigned to two groups. One group will receive Bifidobacterium supplementation for a minimum of one month, while the other group will receive a placebo. Clinical outcomes will then be evaluated to assess whether Bifidobacterium supplementation is associated with faster recovery and reduced relapse rates compared with placebo.
Interventions
DIETARY_SUPPLEMENTLive Combined Bifidobacterium
the Bifidobacterium genus supplement
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Age 18 to 60 years * Diagnosis of acute central serous chorioretinopathy (CSC) (affected eye: ① FFA and ICGA showing typical CSC manifestations, ② presence of subretinal fluid (SRF) at the macular fovea, ③ disease duration ≤ 6 months) * Best Corrected Visual Acuity (BCVA): 53 to 86 letters * Other: No significant systemic diseases, signed informed consent, and able to commit to follow-up
Exclusion criteria
* Presence of significant systemic diseases * BCVA of 20/200 or worse * Presence of choroidal or retinal atrophy in the macular fovea of the affected eye * Presence of choroidal neovascularization (CNV), age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), diabetic retinopathy (DR), choroidal hemangioma, pigment epithelial detachment (PED), etc., in the affected eye * High myopia in the affected eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Corrected Visual Acuity | through study completion, an average of one year | BCVA is commonly assessed during eye exams to determine the effectiveness of vision correction and to evaluate the impact of eye conditions or diseases on vision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Retinal Thickness (CRT) | through study completion, an average of one year | Central Retinal Thickness is typically assessed using imaging techniques such as optical coherence tomography (OCT), which provides detailed cross-sectional images of the retina, allowing for accurate measurement of its thickness. |
| the thickness of Subretinal Fluid (SRF) | through study completion, an average of one year | Subretinal fluid can cause vision distortion and may require medical intervention to address the underlying condition and reduce fluid accumulation. |
| the thickness of Choroid | through study completion, an average of one year | Choroidal hyperpermeability is one of the key mechanisms underlying the pathogenesis of central serous chorioretinopathy (CSC). |
| Choroidal Vascular Index (CVI) | through study completion, an average of one year | This is a ratio or index that quantifies the proportion of the choroid occupied by blood vessels compared to the total choroidal area. It provides a measure of the relative density of the choroidal vasculature. |
| Choroidal Vascular Volume (CVV) | through study completion, an average of one year | This measures the total volume of the choroidal blood vessels within a specific area of the choroid. It reflects the overall blood vessel density and the amount of blood flowing through the choroidal vasculature. |
Countries
China
Contacts
CONTACTWeixin Zheng, master
CONTACTPanpan Ye, doctor
PRINCIPAL_INVESTIGATORPanpan Ye, doctor
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Outcome results
None listed