Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to 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
This study mainly observed the ischemic index and vascular leakage index changes on ultra-wide field fluorescence angiography after anti-VEGF treatment , and whether these changes correlated with treatment efficacy in patients with macular edema secondary to retinal vein occlusion.
详细描述
Ultra-wide field fluorescence angiography can clearly observe the peripheral retina. This study mainly observes the ischemic index and vascular leakage index changes on UWFA after anti-VEGF treatment and evaluates these changes associated with treatment efficacy in patients with macular edema 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 older
- •Macular edema secondary to CRVO,BRVO or HRVO
- •Duration of RVO not more than 4 months
- •Naïve patients. Patient with previous RVO (more than 12 months before the inclusion date) completely resolved (normalization of visual acuity and fundus examination) and who have experienced a recurrence of RVO are also considered naive
- •Patient who agrees to participate in 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
研究组 & 干预措施
UWFA-RVO-ME
Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab
干预措施: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] (Drug)
UWFA-RVO-ME
Ultra-wide-field fundus fluorescein angiography on patients with macular edema secondary to retinal vein occlusion treated with Ranibizumab
干预措施: Ultra-wide Fluorescein Angiography (Device)
结局指标
主要结局
Change in non-perfused areas in different retinal area
时间窗: Baseline and 1,2,3,4,6,9 and 12 months
Change in non-perfused areas in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
Change in vascular leakage index in different retinal area
时间窗: Baseline and 1,2,3,4,6,9 and 12 months
Change in vascular leakage index in different retinal area from baseline to 1,2,3,4,6,9 and 12 months
次要结局
- Change in best corrected visual acuity(Baseline and 1,2,3,4,6,9 and 12 months)
- Change in central macular thickness(Baseline and 1,2,3,4,6,9 and 12 months)
研究者
Changzheng Chen
Chief of Department of Ophthalmology
Renmin Hospital of Wuhan University