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临床试验/NCT04459949
NCT04459949Unknown不适用

Comparative Study of Sharkskin Versus Grieshaber Forceps During ILM Peeling

Wills Eye0 个研究点目标入组 100 人开始时间: 2020年7月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Surgical time

研究概览

简要总结

The purpose of this study is to compare the performance and anatomic outcomes of the Sharkskin internal limiting membrane (ILM) forceps and the Grieshaber ILM forceps in macular surgery.

Peeling of the ILM is a difficult aspect of vitreoretinal surgery and often daunting task from a vitreoretinal fellow's perspective. The hypothesis is that the newer Sharkskin forceps have a larger platform and micro-abrasions along the forcep surface to increase grasping ability and potentially limit trauma to the retina surface compared to the Grieshaber forceps. This project may also serve as an education tool for fellows learning the basics of ILM peeling.

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
Single (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

  • Macular pathology

排除标准

  • No prior vitreoretinal surgery

结局指标

主要结局

Surgical time

时间窗: During surgery

次要结局

  • Ease of peeling - masked grader(Through study completion, up to one year)
  • Ease of peeling - surgeon(During surgery)

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

MidAtlantic Retina

Principal Investigator

Wills Eye

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