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临床试验/NCT02988583
NCT02988583已完成不适用

Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial

Khon Kaen University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月最近更新:
适应症
干预措施

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

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

Experimental

Retinal detachment surgery using low viscosity silicone oil

干预措施: Surgery using low viscosity silicone oil (Device)

high viscosity silicone oil

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yosanan Yospaiboon

Professor

Khon Kaen University

研究点 (2)

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