The goal of this clinical trial is to evaluate the synergistic efficacy and safety of the Tongluo Huayu Formula combined with conventional Western medical treatment for RVO, thereby providing high-quality evidence to support its subsequent clinical promotion and application. The control group will receive conventional Western medical therapy, including laser photocoagulation and intravitreal Conbercept injection. Specifically, Conbercept will be injected intravitreally once a month for 3 consecutive months. If large areas of retinal non-perfusion or fundus neovascularization occur during the study period, laser photocoagulation will be administered based on the patient's condition. The experimental group will receive the Tongluo Huayu Formula in addition to the standard therapy provided to the control group. The Tongluo Huayu Formula will be administered for 1 month. Relevant examinations and assessments for participants in both groups will be conducted at baseline (before treatment), and at 1, 2, 3, and 6 months after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Intravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
The Tongluo Huayu Formula will be administered for 1 month.
Laser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Central Macular Thickness（CMT）
Central Macular Thickness (CMT) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment.
Best Corrected Visual Acuity(BCVA)
Best Corrected Visual Acuity (BCVA) assessed using the standard logarithmic visual acuity chart, reported as LogMAR score.
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Superficial retinal capillary plexus vessel density(VD-SCP)
Superficial retinal capillary plexus vessel density (VD-SCP) measured by OCTA, reported as percentage (%) of vessel area.
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Deep retinal capillary plexus vessel density (VD-DCP)
Deep retinal capillary plexus vessel density (VD-DCP) measured by OCTA, reported as percentage (%) of vessel area.
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Foveal Avascular Zone area(FAZ)
Foveal Avascular Zone area(FAZ) measured by Optical Coherence Tomography Angiography (OCTA) in Square millimeters (mm²).
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell Layer Thickness(GCL)
Ganglion Cell Layer Thickness(GCL) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Ganglion Cell-Inner Plexiform Layer Thickness
Ganglion Cell-Inner Plexiform Layer Thickness measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
Carotid plaque
Presence of carotid plaque (yes/no) measured by B-mode ultrasound.
Time frame: Baseline, and at 3 and 6 months after treatment
Retinal circulation time
Retinal circulation time measured by fundus fluorescein angiography (FFA) in Seconds (s)- typically arm-to-retina circulation time.
Time frame: Baseline, and at 3 and 6 months after treatment
Retrobulbar blood flow
Retrobulbar blood flow parameters measured by color Doppler ultrasound include peak systolic velocity (PSV, cm/s) and end-diastolic velocity (EDV, cm/s) and resistive index (RI).
Time frame: Baseline, and at 3 and 6 months after treatment
Gut microbiota
Gut microbiota measured by 16S rRNA sequencing include Alpha diversity (e.g., Shannon index) or Relative abundance of specific taxa (%).
Time frame: Baseline, and at 1, 2, 3, and 6 months after treatment
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