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临床试验/NCT04427995
NCT04427995终止不适用

Standalone OMNI Surgical System for Open-angle Glaucoma

Iqbal Ahmed1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
30
试验地点
1
主要终点
Lower Intraocular Pressure and medication dependence

研究概览

简要总结

The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising MIGS procedure. It combines two procedures known as trabeculotomy and viscodilation of Schlemm's canal in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for certain indications in ophthalmic surgery. To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

详细描述

The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP).1 The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising procedure which targets the conventional outflow pathway.2 This device treats the trabecular meshwork, Schlemm's canal and the distal collector channels, all conventional pathway points of aqueous outflow resistance. Its designed microcatheter allows for cannulation of Schlemm's canal, dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by stripping the trabecular meshwork will retracting the catheter.3 Goniotomy-assisted transluminal trabeculotomy (GATT) has shown promising results in using an ab interno approach to cleave the trabecular meshwork.4 Alternatively, viscodilation alone has also shown an IOP lowering effect. 5 The OMNI Surgical System combines both procedures in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures.6 To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Other forms of glaucoma,
  • prior incisional glaucoma surgery,
  • prior corneal graft (PKP, DALK, DSAEK, DMEK),
  • Shafer angle grading <2 in 2 or more quadrants.

结局指标

主要结局

Lower Intraocular Pressure and medication dependence

时间窗: Postoperative week 1, month 1, month 3, annually

Change in IOP less than or equal to baseline with a medication reduction to 1 or less or an IOP change of 20% or less from baseline with medication

次要结局

  • Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma.(1 month post operatively)

研究者

发起方
Iqbal Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Iqbal Ahmed

Principal Investigator

Prism Eye Institute

研究点 (1)

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