NCT01789437已完成不适用
Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change of outer arteriolar diameter
研究概览
简要总结
to evaluate the wall-to-lumen ratio (WLR) of retinal arterioles in hypertensive patients with retinal vein occlusion (RVO) before and after dexamethasone intravitreal implant 0.7 mg (DEX) compared to a matched control group of normal eyes in non-hypertensive subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to provide written informed consent and comply with study assessments for the full duration of the study;
- •age > 20 years;
- •decreased visual acuity as a result of clinically detectable ME associated with either CRVO or BRVO;
- •the duration of macular edema was required to be between 4 and 24 weeks for both CRVO and BRVO;
- •retinal thickness in the central subfield (as measured using optical coherence tomography) had to be > 350 µm in the study eye.
排除标准
- •the exclusion criteria were as follows: diabetes; previous intravitreal anti-VEGF therapy or intravitreal steroid therapy; previous photodynamic therapy or focal laser; active retinal or optic disc neovascularization; active or history of choroidal neovascularization; presence of rubeosis iridis; any active infection; glaucoma, current ocular hypertension, or a history of steroid-induced intraocular pressure (IOP) increase in either eye; or concurrent eye disease in the study eye that could compromise visual acuity (e.g., choroidal neovascularization, diabetic retinopathy, epiretinal membrane).
结局指标
主要结局
change of outer arteriolar diameter
时间窗: the primary endpoint was at 6 months
change of inner arteriolar diameter
时间窗: the primary endpoint was at 6 months
次要结局
- Secondary outcome measures were as follows: adverse ocular events; mean change in visual acuity; and mean change in central macular thickness.(Outcomes were analyzed at 4 intermediate time points: 30, 60, 90, and 150 days.)
研究者
Andrea Russo
Dr.
Università degli Studi di Brescia
研究点 (2)
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