跳至主要内容
临床试验/NCT02990143
NCT02990143终止2 期

The Effectiveness of Ologen® Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve Surgery (AGV-FP7)

The New York Eye & Ear Infirmary1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年1月15日最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
30
试验地点
1
主要终点
The Effectiveness of ologen® Collagen Matrix in preventing intraocular pressure (IOP) spikes after Ahmed Glaucoma Valve Surgery (AGV-FP7)

研究概览

简要总结

The purpose of this study is to investigate whether placing Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

详细描述

Uncontrolled glaucoma may require surgical intervention. Glaucoma drainage implants such as AGV-FP7 are in wide use upon glaucoma and comprehensive surgeons. The success of aqueous shunt surgery depends on the formation and maintenance of a thin permeable capsule around the posterior plate of the aqueous shunt. Encapsulated bleb formation, where the capsule is thick and elevated, is a common cause of drainage failure in the early post-operative period. This finding is usually accompanied by elevated intraocular pressure (IOP), which requires additional intervention, often surgical and therefore reduces the success rate of the initial surgery.

Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery. This device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.

This study is to investigate whether placing Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

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
Single (Participant)

入排标准

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

入选标准

  • Age ≥18 years.
  • Uncontrolled treated glaucoma requiring AGV-FP7 surgery.
  • Subject must be able and willing to cooperate with investigation plan.
  • Subject must be able and willing to complete postoperative follow-up requirements
  • Subject must be willing to sign informed consent form

排除标准

  • Known allergic reaction to porcine collagen
  • History of uveitis
  • Corneal opacity or irregularity, preventing visualization of patency of tip of tube or accurate applanation
  • History of scleral buckle

结局指标

主要结局

The Effectiveness of ologen® Collagen Matrix in preventing intraocular pressure (IOP) spikes after Ahmed Glaucoma Valve Surgery (AGV-FP7)

时间窗: 1 year

Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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