跳至主要内容
临床试验/NCT04019210
NCT04019210Unknown不适用

Modified Trabeculectomy a New Procedure for Glaucoma Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
17
试验地点
1
主要终点
IOP

研究概览

简要总结

A combination of hypotony, flat anterior chamber and choroidal detachment is the most common complications after filtering surgery. The purpose of this study is to present a new modification in standard trabeculectomy technique to reduce such complications.

详细描述

Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane.

Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm. The horizontal distance between each point is 3.5 mm Figure(1). The application of the cautery continue till the color of the tissue becomes brown.

Then with aid of a 23-gauge needle we penetrate these cauterized points to create 4 holes, each of them is nearly 0.3-0.5 mm in length (the opening of each hole takes the shape of a slit). Through one of these holes iridectomy is done.

These holes drain the aqueous under the scleral flap with anatomical preservation of tissue in between.

Close the scleral flap by two 10-0 nylon suture.

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
30 Years 至 62 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1ery glacouma

排除标准

  • Previous surgery

研究组 & 干预措施

MODIFIED TRABECULECTOMY

Experimental

Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane.

Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm.

干预措施: MODIFIED TRABECULECTOMY (Procedure)

结局指标

主要结局

IOP

时间窗: 6 month

Decreased IOP with normal depth anterior chamber measured by Tonopen

次要结局

未报告次要终点

研究者

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

Hassan Lotfy Fahmy

Clinical Professor

Assiut University

研究点 (1)

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