Comparaison de la Vitrectomie précoce et de la Surveillance Simple Dans la Prise en Charge Des hémorragies du vitré spontanées EVIDENSE Early VItrectomy in DENse Spontaneous Vitreous HEmorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Rate of retinal detachment
研究概览
简要总结
The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.
The hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.
详细描述
The aim of the protocol is to compare the ocular outcomes after spontaneous vitreous hemorrhage treated with an early vitrectomy versus ultrasound monitoring with late vitrectomy.
The hypothesis is that an early vitrectomy could decrease the rate of retinal detachment occurring after a spontaneous vitreous hemorrhage.
Scientific background Spontaneous vitreous hemorrhage may occur after spontaneous posterior vitreous detachment and causes retinal break and retinal detachment in about 70% and 40% of cases respectively. The fundus examination and ultrasound have limited sensitivity to detect retinal breaks in these cases. Some retrospective studies have highlighted the benefit of an early vitrectomy for decreasing the rate of visual loss due to retinal detachment in these cases. However, to date, there is no national or international consensus regarding the management of spontaneous vitreous hemorrhage and the timing of vitrectomy.
Study design Prospective randomized clinical trial Primary objective To compare the results of an early vitrectomy versus ultrasound and fundus observation in spontaneous vitreous hemorrhage.
Secondary objectives To evaluate the rate of retinal complications in spontaneous vitreous hemorrhage treated either with early or delayed vitrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > or = 18 years old
- •Spontaneous vitreous hemorrhage which is :
- •secondary to posterior vitreous detachment;
- •acute: which duration is < 15 days,
- •dense: reduced visibility of the fundus
排除标准
- •Retinal detachment at the initial examination
- •Any history of vascular retinal disease (diabetic retinopathy, retinal vein occlusion…)
- •Any history of uveitis, age-related macular degeneration
- •History of a recent ocular traumatism (< 3 months)
- •History of a recent retinal laser treatment (< 3 months) or vitreo-retinal surgery (< 3 months)
- •Absence of oral and written consent
研究组 & 干预措施
Early Vitrectomy
Experimental arm will be treated with early vitrectomy early vitrectomy 7 days after vitreous hemorrhage diagnosis
干预措施: Early vitrectomy (Procedure)
Comparator
Active comparator arm will have fundus and ultrasound observation. Late vitrectomy may be indicated after 3 months of follow-up if needed.
Late vitrectomy will be performed in case of persistant vitreous hemorrhage after 3 months of folllow-up
干预措施: Early vitrectomy (Procedure)
结局指标
主要结局
Rate of retinal detachment
时间窗: 6 months after intervention
number of eyes with a retinal detachment in each group. The presence of retinal detachment will be assessed on fundus examination
次要结局
- Rate of retinal breaks(6 months after intervention)
- Visual acuity(6 months after intervention)
- Rate of eyes with a loss of 5 letters or more(6 months after intervention)
- Rate of cataract(6 months after intervention)
- Rate vitreo-retinal proliferation(6 months after intervention)