The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
研究概览
简要总结
The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following pars plana vitrectomy.
详细描述
The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following pars plana vitrectomy.
The study will include 60 patients with a temporary silicone oil tamponade who will be surgically treated with pars plana vitrectomy for rhegmatogenous retinal detachment and proliferative vitreoretinopathy. All subjects will be subdued to complete ophthalmologic examinations, measurements of the retinal nerve fiber layer thickness by an OCT examination, tests of the visual field with the use of an Octopus computed perimeter (automated static perimetry) and FDT-perimetry - both prior to the surgery, and on control visits for check-up during the postoperative period.
All results provided by postoperative examinations will be compared with one another.
The study is expected to provide data on the effect of the silicone oil on thickness of the retinal nerve fiber layer. It is also planned to show possibilities and advantages of OCT as a method of choice in the follow-up of patients with intraocular silicone oil tamponade.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with rhegmatogenous retinal detachment
排除标准
- •preexistent glaucoma
- •previous retinal surgery
- •placement of scleral buckle during surgery
- •patients with more than 1/2 of emulsified silicone oil in anterior chamber postoperatively
- •patients who develop silicone oil keratopathy postoperatively
- •patients who develop silicone oil cataract which blocks visualization of posterior segment
研究组 & 干预措施
NO IOP
Patients without raised IOP
干预措施: Optical coherence tomography (Other)
RAISED IOP
Patients with raised IOP
干预措施: Optical coherence tomography (Other)
RAISED IOP
Patients with raised IOP
干预措施: Local medical treatment of raised intraocular pressure (Drug)
结局指标
主要结局
Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
时间窗: 6 months
Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade.
次要结局
- Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade(6 months)
研究者
Mia Zoric Geber
Mia Zoric Geber, MD
University Hospital "Sestre Milosrdnice"