Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Emulsification rate
研究概览
简要总结
Silicone oil has been used as a surgical tool in complicated retinal detachment surgery. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. Silicone oil emulsification is one of the complication that may result in severe sequels that are difficult to treat. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. This prospective study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.
详细描述
Silicone oil has been used as a surgical tool in retinal detachment surgery since 1962. The National Eye Institute Silicone Study demonstrated the superiority of silicone oil compared with sulfur hexafluoride, and its comparability with perfluoropropane, for the treatment of complicated retinal detachment associated with advanced proliferative vitreoretinopathy. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. These complications may occur during surgery and after the surgery. Silicone oil emulsification is one of the complication that may result in severe sequels including band-shaped keratopathy, complicated glaucoma and retinopathy that are difficult to treat. The commonly used silicone oil includes low viscosity and high viscosity type. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. Retrospective medical review of these patients using 1000-vs 5000-centistoke silicone oil demonstrated that anatomic and visual acuity outcomes, as well as complication rates including emulsification, were similar in both groups. To the best of authors' knowledge, there has been no prospective study on this subject. This study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade
- •Age ≥ 18 years
- •Sign informed consent form
排除标准
- •Inflammatory eye diseases i.e. uveitis
- •Corneal scar
- •History of scleral buckling procedure
- •History of using surfactant drugs
研究组 & 干预措施
low viscosity silicone oil
Retinal detachment surgery using low viscosity silicone oil
干预措施: Surgery using low viscosity silicone oil (Device)
high viscosity silicone oil
Retinal detachment surgery using high viscosity silicone oil
干预措施: Surgery using high viscosity silicone oil (Device)
结局指标
主要结局
Emulsification rate
时间窗: 12 months
Proportion of patients developing silicone oil emulsification in each arm/group.
次要结局
- Retina reattachment rate(12 months)
- visual improvement(12 months)
研究者
Yosanan Yospaiboon
Professor
Khon Kaen University
