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临床试验/NCT05053698
NCT05053698已完成不适用

Evolution of Aqueous Flare in Rhegmatogenous Retinal Detachments Treated With Gas or Silicone Oil Tamponade.

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)

研究概览

简要总结

To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients :

  • Group 1 : 48 eyes primarily treated with gas tamponade
  • Group 2 : 11 eyes primarily treated with silicone oil tamponade
  • Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse
  • Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • adult patients
  • patients who underwent surgery for rhegmatogenous retinal detachment (silicone or gas tamponade)
  • aqueous flare measurement carried out preoperatively and postoperatively at 2-4 weeks and 3 months

排除标准

  • diabetic retinopathy
  • non rhegmatogenous retinal detachment
  • active uveitis
  • pseudoexfoliation syndrome.

结局指标

主要结局

Change in aqueous flare measurement (expressed as photon counts per millisecond and measured with a laser flare-cell meter)

时间窗: preoperatively and postoperatively at 2 weeks and 3 months after surgery

Aqueous flare was measured preoperatively and postoperatively at 2 weeks, 4 weeks and 3 months with a laser flare-cell meter, in patients treated for RRD

次要结局

  • Change in aqueous flare measurement (measured with a laser flare-cell meter)(postoperatively at 2 weeks and 3 months after surgery)
  • Evolution of macular status(preoperatively and postoperatively at 3 months)
  • Relapsing status (yes or not)(at 3 months postoperative)
  • Comparison of aqueous flare values (measured with a laser flare-cell meter) between patients who relapsed and patients who didn't relapse(preoperative)
  • Evolution of measures of visual acuity(preoperatively and postoperatively at 3 months)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

BERROD Jean-Paul

Professor BERROD Jean-Paul

Central Hospital, Nancy, France

研究点 (1)

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