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临床试验/NCT01454466
NCT01454466已完成1 期

Partial Posterior Hyaloidectomy in Macular Surgery : A Modified Procedure of Vitrectomy to Prevent Retinal Break Related to Induction of a Posterior Vitreous Detachment

Samsung Medical Center0 个研究点目标入组 50 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
50
主要终点
incidence of intraoperative and postoperative retinal break related to surgery

研究概览

简要总结

To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal breaks related to induction of a posterior vitreous detachment

详细描述

The induction of a posterior vitreous detachment (IPVD) during vitrectomy have been suggested as one of the etiologies of iatrogenic retinal break related to vitrectomy.The iatrogenic retinal breaks related to IPVD usually develop near or anterior to the equatorial region.

Thus, the investigators hypothesized that this complication could be prevented by restricting the extent of IPVD, and planned a modified procedure of vitrectomy in which the extent of IPVD and removal of vitreous cortex was restricted to about slightly beyond the margin of temporal major vascular arcade.

The investigators have termed this procedure, partial posterior hyaloidectomy. Unlike RRD or proliferative diabetic retinopathy, lesions are localized within the major vascular arcade in macular disorders so that macular disorders could be an eligible indication for this procedure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively

排除标准

  • history of previous intraocular surgery

结局指标

主要结局

incidence of intraoperative and postoperative retinal break related to surgery

时间窗: postoperative 3 to 6 months

The eyes that completed a follow-up of at least 3 months were included in the result analysis. The incidence of retinal breaks related to the surgery was measured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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