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临床试验/NCT06837610
NCT06837610进行中(未招募)不适用

Inverted T Trabeculectomy for Primary Congenital Glaucoma, A Novel Technique

Benha University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25
试验地点
2
主要终点
Post op IOP

研究概览

简要总结

This study aims to evaluate the safety and efficacy of novel Inverted T trabeculectomy in Primary Congenital Glaucoma (PCG). It enrolled 50 eyes of 25 children with PCG. The mean age at the time of surgery was 12±11 months, and the mean presenting IOP was 40±4 mmHg. Patients with previous intra-ocular or conjunctival surgery, those who had significant ocular trauma, and patients with congenital glaucoma associated with ocular anomalies diseases were excluded from the study. All patients had Inverted T trabeculectomy under general anesthesia. The IOP in the operated eyes was followed up for 36 months.

详细描述

This study included patients from the glaucoma clinic at Benha University Hospital between April 2015 and October 2017. All were diagnosed with PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months. Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from the study.

The procedure principles and potential complications were discussed with the children's parents or legal guardians, and they gave written informed consent before surgery. This study was approved by the Benha Faculty of Medicine's ethical committee (Approval number RC 9-1-2025) and conducted according to Helsinki's declaration.

All patients underwent complete ophthalmic examination under general anaesthesia before surgery. IOP was measured 5 minutes after injecting intravenous Ketamine 1mg/kg for induction of anaesthesia. We used a Perkins tonometer (Haag-Streit, UK) to measure the IOP before applying the eyelid speculum. Corneal clarity was assessed under a surgical microscope, the corneal diameter was recorded using a surgical caliber, and fundus examination was done by indirect ophthalmoscope. A surgical Swan Jacob gonioprism assessed the anterior chamber angle when the cornea was clear enough to achieve a good view.

All surgeries were performed under general anaesthesia by the same surgeon (AEH).

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

盲法说明

purposefully concealing treatment assignment to prevent outcomes from being influenced by biases due to knowledge of that assignment

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months

排除标准

  • Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from the study

结局指标

主要结局

Post op IOP

时间窗: 18 months

IOP lower than 21 mmHg or \> 20% reduction from the baseline IOP in at least two consecutive follow-up visits without IOP-lowering medications and without vision-threatening complications

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

Mohamed Abdelzaher Awwad

Dr

Benha University

研究点 (2)

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