Study on repairing effect of collateral therapy on macular microvascular injury in branch retinal vein occlusio

Phase 1

• Conditions: Branch retinal vein occlusion

• Registration Number: ITMCTR2000004079
• Lead Sponsor: Eye Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the following Western medicine diagnostic criteria for branch retinal vein occlusion and TCM diagnostic criteria, and the course of disease is more than 2 weeks;
2. Aged between 40 and 70 years old;
3. Subjects who fully understand the project and voluntarily sign the informed consent;
Western medicine diagnostic criteria;
(1) Sudden vision loss or black shadows in front of the eyes;
(2) Dilated and tortuous retinal veins in the fundus, hemorrhage and edema on the surface of the affected veins;
(3) Fundus fluorescein angiography: retinal vein filling time is delayed, capillary leakage, and no perfusion area is visible;
(4) OCT examination showed macular edema, and the thickness of the fovea was more than 300um.
TCM diagnostic criteria:
Main symptoms:
(1) decreased vision;
(2) retinal hemorrhage, edema, exudation, and venous filling.
Secondary symptoms:
(1) body obesity, less gas and lazy speech;
(2) dizziness, fatigue, fatigue;
(3) chest tightness, discomfort, swelling full of swelling;
(4) greasy tongue coating or tongue petechiae;
(5) stringy or slippery pulse.
With 2 primary syndromes and 3 secondary syndromes (necessary for tongue picture), the syndrome can be differentiated into this syndrome type.

Exclusion Criteria

1. Patients with late central vision loss;
2. Patients with other fundus diseases;
3. Pregnant or lactating women;
4. Patients with severe cardiovascular and cerebrovascular diseases or severely impaired liver and kidney function and systemic failure;
5. Patients who are participating in clinical trials of other drugs or who have used similar Chinese medicines and other treatments;
6. Subjects who are not willing to participate in clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
vision acuity;Optical coherence tomography angiography (OCTA): central macular thickness (CMT), superficial and deep retina capillary density, non-perfusion area (NPA), foveal avascular area (FAZ).;

Secondary Outcome Measures

Name	Time	Method
Fundus fluorescein angiography (FFA): Record the retinal circulation time, blockage, area of non-perfusion area, and whether there is neovascularization and vascular leakage.;