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临床试验/NCT01051648
NCT01051648已完成2 期

Triamcinolone Assisted Anterior Vitrectomy in Complicated Cataract Surgery and Anterior Segment Reconstruction

Cairo University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Proper visualization of vitreous strands in the anterior chamber of the eye

研究概览

简要总结

Injecting Triamcinolone acetenoide for visualizing and removing vitreous from the anterior chamber.

详细描述

The research followed the tenets of the Declaration of Helsinki, ;informed consent were obtained from patients where all details of the procedure were explained with emphasis on the intended outcome. The research was approved by the institutional review board.

Ten eyes of 10 patients were divided into 2 groups. Group A included 6 eyes of 6 patients with accidental rupture of posterior capsule during cataract surgery (5 eyes underwent phacoemulsification technique and one underwent ECCE). Group B included four eyes of 4 patients undergoing anterior segment reconstruction (anterior vitrectomy, secondary IOL Implantation and iris repair by direct approximation using 10/0 prolene sutures). In group A the mean age was 68.1 ± 10.93 years (range 47 to 79 years), 3 were males and 3 were females. In group B the mean age was 14 ± 5.6 years (range 9 to 22 years), 3 were males and one female. Demographic data and pre-operative Information are presented in table 1 and 2.

In all patients triamcinolone acetonide was prepared by keeping the bottle vertical to allow sedimentation of crystals thus removing the vehicle. It was then injected into the anterior chamber (2 ml with concentration 20 mg/ml) just prior to anterior vitrectomy. The direction of the tip of the needle was kept away from the corneal endothelium to minimize endothelial toxicity. Triamcinolone was removed as quickly & completely as possible after finishing anterior vitrectomy.

Postoperative regimen included topical steroids and antibiotics for about 4-6 weeks. Topical anti-glaucoma drugs were used in cases of high postoperative IOP for few days until stabilization of IOP. Follow up period ranged from 2 months up to 27 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
47 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with vitreous in the anterior chamber whether in
  • complicated cataract surgery
  • disorganized anterior segment structures

排除标准

  • Glaucoma patients
  • Intra ocular infections
  • Bacterial or fungal

研究组 & 干预措施

Triamcinolone acetenoide

Experimental

Intra ocular injection of triamcinolone acetonide to visualize vitreous strands in the anterior chamber of the eye in complicated cataract surgery

干预措施: Intra ocular injection of triamcinolone acetonide (Drug)

结局指标

主要结局

Proper visualization of vitreous strands in the anterior chamber of the eye

时间窗: immediately

次要结局

  • intraocular pressure rise(2-3 weeks)

研究者

申办方类型
Other

研究点 (2)

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