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临床试验/NCT04280770
NCT04280770已完成不适用

Surgical Techniques for Epiretinal Membrane Removal in Pars Plana Vitrectomy: A Comparative Study Between 20-Gauge and 23-Gauge Vitrectomy

Ain Shams University0 个研究点目标入组 50 人开始时间: 2009年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
success rate

研究概览

简要总结

Objective: to evaluate anatomical and visual outcomes of 23-gauge vitrectomy for retinal detachment with silicone oil injection in fifty cases. The rate of recurrence, the incidence of proliferative vitreoretinopathy (PVR) and the value of risk factors.

Participants and Methods: fifty cases with RD with mixture of epiretinal and subretinal membranes were collected. Pars plan vitrectomy, 23gauge vitrectomy were done to these cases, then silicone oil removed 6 weeks after primary surgery.

Main Outcome Measures: The anatomical success rate,the failure rate ,the rate of retinal breaks in both groups, and reproliferation rate.

详细描述

50 Patients were included if they had retinal detachment, moderate degrees of PVR, PVR ≥ Grade C, previous buckle surgery and pseudophakia. A good and correct assessment of the detached retina was done. Investigator followed the Lincoff rules to find the retinal breaks. Investigator performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Investigator used Perfluorocarbon liquid (PFCL) for attaching the retina with its gravity. Then performing PFCL against air exchange.The retina will be attached under air tamponade. Laser photocoagulation was performed in the air-filled eye.

Investigator applied the laser effects confluently surrounding all retinal breaks. Then silicone oil (1000 centistokes) was injected as a final step and permanent tamponade.After 3-6 months investigator removed the silicone and examined the retina for 6 weeks after surgery to detect the recurrent cases.

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, Care Provider, Outcomes Assessor)

盲法说明

Each of the recruited patients were assigned a study number and randomized in accordance with a simple block randomization scheme.

入排标准

年龄范围
23 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • they had retinal detachment,
  • moderate degrees of PVR
  • PVR ≥ Grade C
  • previous buckle surgery
  • pseudophakia.

排除标准

  • the retinal tear was greater than 90 degrees
  • presence of intravitreal foreign body
  • previous vitrectomy done before
  • if follow-up data were unavailable for a minimum follow-up of 6 months following the final retinal procedure.

结局指标

主要结局

success rate

时间窗: 42 days

success rate after first RD surgery and silicone oil removal

number of surgical interference

时间窗: 4 years

numbers of vitrectomies done after silicone oil removal

The failure rate

时间窗: 42 days

The failure rate after silicone oil removal

次要结局

  • lower retinal breaks(4 years)

研究者

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

khaled hamdi elbaklish

Clinical Professor

Ain Shams University

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