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临床试验/NCT07363889
NCT07363889招募中不适用

Vitrectomy Machine Versus Spring Loaded Syringe for Active Silicon Oil Extraxtion

Sohag University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Incidence of complications

研究概览

简要总结

The aim of our study is to compare between two techniques used for active SOR. The outcomes include efficiency and safety.

Patients with silicon filled eyes and prepared for SOR 540 eyes of 505 patients (one eye in 470 patients, and both eyes in 35 patients) were enrolled in the study.

All eyes underwent SOR using 23-Gauge PPV. The eyes were classified according to the surgical technique used for SOR into two groups:- Group A: SOR was performed using SO extraction program built in Optikon vitrectomy device Group B: SOR was performed using modified spring loaded syringe.

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
Double (Participant, 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 subjected previously to pars plana vitrectomy with silicon oil tamponade.

排除标准

  • Recurrent retinal detachment
  • Previous scleral buckling
  • Previous glaucoma surgery
  • Bleeding tendencies
  • Anterior staphyloma

研究组 & 干预措施

Group A

Active Comparator

Conventional technique using vitrectomy machine

干预措施: Vitrectomy machine (Device)

Group B

Active Comparator

Spring loaded syringe for silicon oil extraction

干预措施: Spring loaded syringe (Device)

结局指标

主要结局

Incidence of complications

时间窗: During the surgical procedure and up to 3 months postoperative

Incidence of operative and postoperative complications in both groups

次要结局

未报告次要终点

研究者

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

Alaa Abdalsadek Ahmed Sinjab

Lecturer of Ophthalmology

Sohag University

研究点 (1)

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