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.
Patients who meet the aforementioned Western diagnostic criteria and TCM syndrome differentiation criteria for RVO, and are complicated with macular edema.
Patients who fully understand the study and voluntarily sign the informed consent form.
Patients currently participating in other clinical trials or receiving concomitant use of similar traditional Chinese medicines or other therapies.
Patients with other fundus retinal diseases, such as neovascular glaucoma or iris neovascularization.
Patients with severe systemic diseases, such as rheumatism or systemic lupus erythematosus.
Women who are pregnant or breastfeeding (lactating).
Parallel
Conbercept Ophthalmic Injection
DrugIntravitreal injection of Conbercept will be administered once a month for 3 consecutive months.
Tongluo Huayu Formula
Other interventionThe Tongluo Huayu Formula will be administered for 1 month.
Laser Photocoagulation
Procedure/SurgeryLaser photocoagulation will be administered if large areas of retinal non-perfusion or fundus neovascularization occur.
Central Macular Thickness（CMT）
Central Macular Thickness (CMT) measured by Optical Coherence Tomography Angiography (OCTA) in micrometers (μm).
Best Corrected Visual Acuity(BCVA)
Best Corrected Visual Acuity (BCVA) assessed using the standard logarithmic visual acuity chart, reported as LogMAR score.
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.
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.
Foveal Avascular Zone area(FAZ)
Foveal Avascular Zone area(FAZ) measured by Optical Coherence Tomography Angiography (OCTA) in Square millimeters (mm²).
Temperature
Temperature measured by an electronic thermometer in degrees Celsius (°C).
Heart rate
Heart rate measured by automatic blood pressure monitor in beats per minute (bpm).
Blood pressure
Blood pressure measured by automatic blood pressure monitor in Millimeters of mercury (mmHg) - report systolic and diastolic values separately.
Complete Blood Count
Complete Blood Count, including white blood cell count (×10⁹/L), red blood cell count (×10¹²/L), hemoglobin (g/L), and platelet count (×10⁹/L), will be assessed via blood draw.
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First Affiliated Hospital of Zhejiang University
Lead sponsor
Zhejiang Provincial Tongde Hospital
Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborator
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