跳至主要内容
临床试验/NCT06536569
NCT06536569尚未招募4 期

A Comparison of the Efficacy of 25g Grieshaber Sharkskin ILM Forceps with Reflex Handle Vs Standard 25g Grieshaber ILM Forceps for Internal Limiting Membrane Peeling

University of British Columbia2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
56
试验地点
2
主要终点
Number of attempts to initiate peeling

研究概览

简要总结

This study is a Single center, prospective, observational, multi surgeon randomized controlled trial. Subjects will be assessed pre-operatively, operatively and at 1 month postoperatively. Clinical evaluations will include measurement of visual acuity and optical coherence tomography (OCT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19y and older patients with symptomatic ERM (grade 2-3) or Macular hole (non flap-requiring) for elective ILM peeling surgery.

排除标准

  • Co-morbid diabetic retinopathy of any grade.
  • Neovascular AMD.
  • Previous vitrectomy.
  • Previous retinal detachment treated with scleral buckle or pneumatic retinopexy.
  • Uncontrolled glaucoma or previous glaucoma surgery.
  • Combined phacovitrectomy.
  • Macula holes with severity requiring flap.

结局指标

主要结局

Number of attempts to initiate peeling

时间窗: Surgery (Operative Visit)

Evaluated by recorded video

次要结局

  • Number of deep retinal grasps(Surgery (Operative Visit))
  • Duration of Peel(Surgery (Operative Visit))
  • Number of handle-ReSite/widefield viewing system lens touches(Surgery (Operative Visit))

研究者

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

Bryon McKay

Principal Investigator

University of British Columbia

研究点 (2)

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