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临床试验/NCT05966545
NCT05966545招募中不适用

Outcomes of Retained Posterior Segment Intraocular Foreign Body Extraction With Coexisting Cataract Via The Limbus or The Pars Plana Route

Zagazig University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
2
主要终点
post-operative retinal detachment

研究概览

简要总结

Intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis. The surgical approach for a posterior segment IOFB is pars plana vitrectomy and its extraction either through the pars plana. our study is to compare limbal route versus pars plana route for extraction of posterior segment IOFB associated with cataract as regard to safety and complications.

详细描述

Penetrating ocular injuries with retained posterior segment intraocular foreign body (IOFB) are relatively common and account for 17% to 41% of ocular injuries.

Intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis, retinal toxicity (secondary to chalcosis, siderosis) and sympathetic ophthalmia.

The surgical approach for a posterior segment IOFB is pars plana vitrectomy (PPV) and its extraction either through the pars plana or the limbus.

PPV and IOFB extraction through sclerotomy is the most commonly used approach. Most commonly retained posterior segment intra ocular foreign bodies (IOFB) are removed after enlarging one of the sclerotomy ports during pars plana vitrectomy. Intra operative complications reported during IOFB extraction were hypotony, vitreous hemorrhage, incarceration of the retina in the wound, IOFB slippage. Reported post-operative complications were glaucoma and retinal detachment. Incidence of post-operative RD was reported to range from 22% to 79% with poor visual outcomes in most cases PPV and IOFB extraction through the limbal route is an alternative approach to remove IOFB. Complications reported were less frequent and include microscopic hyphema and vitreous hemorrhage. The incidence of post-operative retinal detachment after IOFB extraction through limbus was reported to range from 7.15% to 27.7 % The limbal route for retained posterior segment IOFB extraction can offer the following advantages: it allows visually controlled delivery of the IOFB from the posterior pole to the limbal exit and it has no relation to the vitreous base, thus minimizing the risk of creating a peripheral retinal break during extraction of intraocular foreign body, in contrast to the hidden part behind the iris when using the pars plana route.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Eyes with retained posterior segment intraocular foreign body associated with crystalline lens injury.
  • Eyes with retained posterior segment intraocular foreign body associated with coexisting cataract.

排除标准

  • Eyes with pre-operative retinal detachment
  • Eyes with retained posterior segment IOFB with clear lens.
  • Anterior segment IOFBs
  • Severely damaged eyes with an initial visual acuity of no light perception where enucleation is the primary treatment
  • Patients with severely traumatized cornea which can affect visualization during vitrectomy.
  • Pseudophakic eyes.
  • Eyes with endophthalmitis

结局指标

主要结局

post-operative retinal detachment

时间窗: 1, 3 and 6 months

comparing incidence of post-operative retinal detachment after intraocular foreign body extraction via limbus versus pars plana route.

次要结局

  • associated intra operative and post-operative complications.(1, 3 and 6 months)
  • post-operative best corrected visual acuity(1, 3 and 6 months)

研究者

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

Abbas Abomesslam Ali Hashem

assistant lecturer

Zagazig University

研究点 (2)

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