Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in non-perfused areas in different retinal area
研究概览
简要总结
The changes of ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion by ultra-wide field fluorescence angiography (UWFA)
详细描述
In this study, the ischemic index and vascular leakage index, and the effect on macular edema and neovascularization in retinal vein occlusion will be evaluated by ultra-wide field fluorescence angiography (UWFA). UWFA has a wider range than conventional angiography, and can clearly observe the peripheral retina. The purpose of this study is to quantitatively analyze these changes and investigate the effect on macular edema and neovascularization secondary to retinal vein occlusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or more
- •Patients with a diagnosis of CRVO,BRVO or HRVO without macular edema
- •Duration of RVO not more than 4 months
- •Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of RVO are also considered naive
- •Patient who agrees to participate to the study and who has given his/her written, informed consent
排除标准
- •Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period
- •Active or suspected ocular or periocular infection
- •Active severe intraocular inflammation
- •RVO complicated with neovascularization
- •Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
- •Patient already included in the study for the treatment of the fellow eye
- •Pregnant or breastfeeding woman
- •Lack of effective contraception for women of childbearing age
- •Patient taking part in an interventional study
结局指标
主要结局
Change in non-perfused areas in different retinal area
时间窗: Baseline and1，2，3，6，9and 12 months
Change in non-perfused areas in different retinal area from Baseline to 1，2，3，6，9and 12 months
次要结局
- Change in central macular thickness(Baseline and1，2， 3, 6, 9 and 12 months)
- Change in best corrected visual acuity(Baseline and1，2， 3, 6, 9 and 12 months)
研究者
Changzheng Chen
Chief of Department of Ophthalmology
Renmin Hospital of Wuhan University