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临床试验/NCT02795130
NCT02795130Unknown不适用

Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

Ottawa Hospital Research Institute0 个研究点目标入组 40 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Patient comfort

研究概览

简要总结

Small-incision vitrectomy techniques have become increasingly popular, with a number of advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23- and 25-gauge trocar systems theoretically do not require sutured closure. However, a certain fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require suture placement. Poor wound closure puts the patient at increased risk of post-operative hypotony and is associated with increased risk of endophthalmitis. Currently, surgeons are divided as to which suture is the best for sclerotomy closure. The current standard of care is 8-0 polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to work with; however, it triggers a robust inflammatory response. The alternative is 6-0 plain gut suture, which is more difficult to manipulate and thicker, but causes less tissue inflammation1. The purpose of this study is to prospectively evaluate these two options for sclerotomy closure. The results of this study will enable us to minimize patients' post-operative discomfort while maximizing safety outcomes.

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

入选标准

  • Patient of Dr. Michael Dollin
  • Age 18 years and older
  • Scheduled to undergo 23-gauge pars plana vitrectomy for any indication that would most likely require sutures (E.g. retinal detachment)

排除标准

  • History of previous vitrectomy in the study eye
  • History of scleral buckling in the study eye
  • Currently on peri-operative corticosteroid medicines (topical or systemic)
  • Systemic chemotherapy within the preceding 6 months.
  • History of any disorder or medication use associated with conjunctival, scleral, or episcleral inflammation and/or scarring
  • History of narcotic abuse

结局指标

主要结局

Patient comfort

时间窗: 1 month

One month post-operative patient comfort assessed using a 0-10 visual analogue scale

次要结局

  • Complications(1 month)
  • Visual Acuity(1 month)
  • Scleral/conjunctival inflammation(1 month)
  • Intraocular Pressure(1 month)

研究者

申办方类型
Other
责任方
Sponsor

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