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临床试验/NCT03218371
NCT03218371已完成不适用

Scleral Self-indentation During Chandelier-assisted Peripheral Vitrectomy Under Air for Rhegmatogenous Retinal Detachment: A Retrospective Cohort Study.

Dar El Oyoun Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Trimming-induced retinal breaks (TIRB) (yes/ No)

研究概览

简要总结

The investigators compared the incidence of trimming-induced retinal breaks, retinal redetachment rate, and final LogMAR BCVA; between scleral self-indentation and non-indentation during chandelier-assisted peripheral vitrectomy under air for eyes with primary retinal detachment. Self-indentation enables complete trimming of the vitreous base without causing iatrogenic retinal breaks, with a higher retinal reattachment rate, and with less need for chandelier shift than with non-indentation approach.

详细描述

Retrospective cohort study. One hundred and thirty eyes of 130 participants with primary rhegmatogenous retinal detachment were identified. All the participants had undergone a chandelier-assisted peripheral vitrectomy under air. Scleral self-indentation had been used in 68 eyes (study group) (Indentation group), while non-indentation had been used in 62 eyes (comparison group) (Non-indentation group). Outcome variables included: Trimming-induced retinal breaks (TIRB), retinal redetachment rate, final LogMAR BCVA, and intraoperative complications.

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
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • RRD with postoperative follow up > 3 months, without PVR, or with PVR A-B

排除标准

  • RRD with less than 3 months of postoperative follow-up,
  • RRD with proliferative vitreoretinopathy grade C (PVR C),
  • RRD with uveitis,
  • RRD with choroidal detachment,
  • Giant retinal tears,
  • Retinal dialysis,
  • Myopic macular hole RRD,
  • Traumatic RD,
  • Children < 16 years old,
  • The later vitrectomy (if vitrectomy had been performed for RRD in both eyes)

结局指标

主要结局

Trimming-induced retinal breaks (TIRB) (yes/ No)

时间窗: intraoperative

number of eyes with iatrogenic retinal breaks along vitreous base during vitreous base trimming

次要结局

  • retinal redetachment rate (yes/no)(within 3 months)
  • number of Trimming-induced retinal breaks (TIRB)(intraoperative)
  • snellen BCVA > 20/100 (yes/ no)(3 months)
  • Chandelier shift (yes/no)(intraoperative)
  • final LogMAR BCVA(final follow-up visit ( at least 3 months))
  • Local anaesthesia augmentation (yes/no)(intraoperative)

研究者

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

Wael Ahmed Ewais

MD, Lecturer in Department of Ophthalmology, Faculty of Medicine, Cairo University; and consultant vitreoretinal surgeon in Dar El Oyoun Hospital

Dar El Oyoun Hospital

研究点 (1)

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