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临床试验/NCT00300014
NCT00300014Unknown不适用

Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

Asan Medical Center2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
day 1 : intraocular pressure, biomicroscope exam, fundus exam

研究概览

简要总结

The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid exchange.

详细描述

Vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy. Despite measures to prevent and control this bleeding, it can lead to air-fluid exchange in the office or to additional surgery in the operating room. Air-fluid exchange does not result in clear vision immediately after the procedure, and the patient has to maintain a face-down position. Vitreous lavage, a more invasive procedure performed in the operating room, may give rise to complications such as iatrogenic retinal breaks, incarcerations of vitreous in the sclerotomy sites, retinal detachment, rubeosis iridis, neovascular glaucoma, infective endophthalmitis, and sympathetic ophthalmia. In contrast, IVT injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery, while avoiding the face-down position.

We believe that the rapid clearing of vitreous hemorrhage results from as follows: (1) triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood (2) direct vascular stabilizing effect may be induced (3) antiangiogenic effect may play a role.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous vitrectomy due to proliferative diabetic retinopathy
  • Recurrent diabetic vitreous hemorrhage

排除标准

  • Monocular vision
  • Uncontrollable intraocular pressure

结局指标

主要结局

day 1 : intraocular pressure, biomicroscope exam, fundus exam

day 7 : intraocular pressure, biomicroscope exam, fundus exam

2 weeks : intraocular pressure, biomicroscope exam, fundus exam

4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography

2 months : intraocular pressure, biomicroscope exam, fundus exam

3months : intraocular pressure, biomicroscope exam, fundus exam

6 months : intraocular pressure, biomicroscope exam, fundus exam

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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