The Influence of Retinal Oxygenation on the Clinical Outcomes in Eyes With Different Vitreoretinal Pathologies After a Successful Vitrectomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Clinical Data
研究概览
简要总结
Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. However, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery.
Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn the most important factor for the development of macular edema. It is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. However, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case.
To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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, at least 18 years of age.
- •ophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling.
- •persistent diabetic macular edema
- •written informed consent
- •female patients of childbearing potential must have a negative urine pregnancy test.
排除标准
- •uncontrolled systemic disease
- •symptoms of a clinically relevant illness in the 3 weeks before the first study day
- •any ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure
- •history of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy.
- •contraindication to pupil dilation.
- •need for silicon oil or gas after the surgery
- •advanced diabetic retinopathy with vitreoretinal tear and/or bleeding
结局指标
主要结局
Clinical Data
时间窗: 6 months
Visus, OCT
Blood Flow Data
时间窗: 6 months
Oxygenation of retinal blood vessles and retinal blood flow
次要结局
未报告次要终点
研究者
Stefan Sacu
Ass Prof Priv Doz Dr
Medical University of Vienna