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临床试验/NCT05115708
NCT05115708尚未招募不适用

Kahook Dual Blade Ab-interno Trabeculotomy Versus ab Externo Viscotrabeculotomy in Primary Congenital Glaucoma

Mansoura University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
IOP

研究概览

简要总结

This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG.

详细描述

Introduction:

Ab externo viscotrabeculotomy is known as an effective surgical procedure used for managing primary congenital glaucoma (PCG) in which the Schlemm's canal (SC) is identified and a metal probe is inserted into the canal and rotated into the anterior chamber (AC) to perforate the SC inner wall.

Recently, Kahook dual blade (KDB) have been developed as one of the micro-invasive glaucoma surgical tools which removes a strip of the trabecular meshwork(TM) at the angle with superiority to simple goniotomy in treating the angle pathology in PCG.

The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy is a simple procedure usually performed at the time of cataract surgery. It doesn't require sutures, and it carries no risk of bleb leaks or infections. It has a a quicker postoperative visual recovery than most other glaucoma treatments. The KDB device is specifically designed to produce targeted and fine tuned parallel incisions in the trabecular meshwork tissue for a quick and effective glaucoma treatment. The KDB's unique design enables precise excision of diseased trabecular meshwork (TM) to access multiple collector channels.

The KDB's unique design enables the operator to perform excisional goniotomy both during cataract surgery and as a stand alone procedure. The Kahook Dual Blade is a precise, intuitive surgical instrument utilized to perform excisional goniotomy.

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
Double (Participant, Care Provider)

入排标准

年龄范围
1 Month 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • primary congenital glaucoma

排除标准

  • secondary congenital glaucoma

结局指标

主要结局

IOP

时间窗: 2 years

Complete success was defined as an IOP from 6 to 17 mmHg at the 2-year follow-up visit, without AGM or further surgical interventions, without any sign of glaucoma progression (increasing corneal diameter, axial length or cup/disc ratio) and without visual devastating complications. Qualified success was defined as fulfilling the same criteria but with the use of AGM.

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

Amr Mohammed Elsayed Abdelkader

Assisstant professor of ophthalmology

Mansoura University

研究点 (2)

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