跳至主要内容
临床试验/NCT00478790
NCT00478790Unknown3 期

Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

Pro Top & Mediking Company Limited2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
3 期
入组人数
60
试验地点
2
主要终点
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence

研究概览

简要总结

The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.

详细描述

ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

入选标准

  • Age 18 years or over
  • Patient able to cooperate with study procedures and able to perform tests reliably
  • Patient willing to sign informed consent
  • Patient able and willing to complete postoperative follow-up requirements
  • Glaucoma:one/both eyes are affected by glaucoma
  • Pterygium: patient with pterygium

排除标准

  • Known allergic reactions to collagen

结局指标

主要结局

the effectiveness via the reduction of IOP and the incidence of pterygium recurrence

时间窗: 180 day

次要结局

  • the safety via the incidence of complications and adverse events.(180 day)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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