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临床试验/NCT04683055
NCT04683055已完成不适用

Phacoemulsification Combined With Trabeculectomy Versus Phacoemulsification Combined With Trabeculotomy for Treatment of Chronic Angle Closure Glaucoma

Assiut University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月28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
50
试验地点
1
主要终点
Absolute Success

研究概览

简要总结

A prospective, randomized comparative study on adult patients with synechial angle closure glaucoma.

详细描述

Patients were randomized into two groups: group A : patients will undergo two site phacoemulfication combined with trabeculectomy Group B with Phacoemulsification combined with ab-externo trabeculotomy. Preoperative assessments including full ophthalmic examination, anterior segment Optical Coherence Tomography (OCT) of the angle , endothelial cell count , visual fiend Perimetry and Biometry. Patients were followed up: first day, first week and every two months for 6 month. We will compare adverse effects and outcomes in both groups.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with chronic angle closure glaucoma, with or without peripheral anterior synechiae, age more than 18

排除标准

  • •Patient unable for follow up
  • •Patients with corneal or retinal disease that affects visual outcome of surgery
  • •Patients with previous glaucoma procedure in the eye of study

研究组 & 干预措施

Phacoemulsificaiton combined with ab-externo trabeculotomy

Active Comparator

Patients will undergo two phacoemulsification combined with deep sclerectomy and ab-externo trabeculotomy

干预措施: Phacoemulsificaiton combined with ab-externo trabeculotomy (Procedure)

Phacoemulsification combined with trabeculectomy

Active Comparator

Patients will undergo Two site phacoemulsification combined with trabeculectomy with Mitomycin C

干预措施: Phacoemulsification combined with trabeculectomy (Procedure)

结局指标

主要结局

Absolute Success

时间窗: 1,3,6 months

Reduction of IOP more than 30% on no glaucoma drops

Visual outcome

时间窗: 1,3,6 month

Uncorrected visual acuity by Snellen's chart

次要结局

  • Adverse events(1 week, 1 month, 3 months, 6 months)

研究者

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

Mahmoud F. Rateb

Assitant Professor of Ophthalmology

Assiut University

研究点 (1)

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