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临床试验/NCT07830017
NCT07830017已完成不适用

Combined Nasal Goniotomy-Temporal Trabeculotomy Versus Temporal Trabeculotomy for Management of Primary Congenital Glaucoma

Zagazig University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
intra ocular pressure

研究概览

简要总结

Combined nasal goniotomy and temporal trabeculotomy provides effective IOP control in PCG while preserving the superior conjunctiva for future filtering procedures. By expanding the treated angle area and sparing the superior conjunctiva, this operation provides a synergistic approach that may improve long-term management strategies for pediatric glaucoma

详细描述

Primary congenital glaucoma (PCG) is the main category of primary childhood glaucoma. Classically, PCG presents with one or more of the following clinical manifestations: increased corneal diameters, corneal opacification, photophobia, and excessive tearing. The increased intraocular pressure (IOP) in PCG is mainly due to an immature anterior chamber (AC) angle with inadequate aqueous filtration through the trabecular meshwork (TM). 1 Reduction of IOP in PCG relies mainly on surgical treatment. Wide variations in surgical procedures exist for the treatment of PCG, with different principles and steps. The idea behind angle-based surgeries is to remove the main barrier to aqueous filtration and create a direct pathway for aqueous to reach the Schlemm's Canal (SC). Other surgeries, such as trabeculectomy or implantation of Glaucoma drainage devices (GDD), divert the aqueous drainage toward the sub-tenon space away from the occluded TM.2,3 and 4 PCG treatment may entail the need for more than one surgery to correct the IOP. Combining two or more surgical procedures in the same setting may produce a synergistic effect in reducing the IOP while reducing the psychological and surgical burden on PCG patients. In the combined Nasal Goniotomy-Temporal Trabeculotomy (NGTT) procedure, preservation of the superior conjunctiva is an advantage that increases the success rates of further surgeries if needed. 5 In this study, the authors studied a real-world comparison between NGTT and single-site trabeculotomy for the management of PCG patients.

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
None

入排标准

年龄范围
1 Day 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child with primary congenital glaucoma

排除标准

  • associated ocular diseases other than glaucom
  • posterior segment congenital anomalies

研究组 & 干预措施

combined Nasal goniotomy-Temporal trabeculotomy

Active Comparator

combined nasal goniotomy-Temporal trabeculotomy

干预措施: combined Nasal goniotomy-Temporal trabeculotomy (Procedure)

Temporal trabeculotomy

Active Comparator

Temporal trabeculotomy

干预措施: Temporal trabeculotomy (Procedure)

结局指标

主要结局

intra ocular pressure

时间窗: 1 YEAR

post operative IOP compared to preoperative IOP

次要结局

未报告次要终点

研究者

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

Mohammed Alsaeed Al Naimy Habeeb

Professor

Zagazig University

研究点 (1)

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