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临床试验/NCT00524758
NCT00524758已完成3 期

Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Pro Top & Mediking Company Limited1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
20
试验地点
1
主要终点
IOP <21mmHg without anti glaucoma medication

研究概览

简要总结

To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.

The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.

详细描述

Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.

Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.

Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.

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

入选标准

  • Max anti glaucoma medication failed,

排除标准

  • Age less than 18, woman in pregnant, hemodialysis patient

研究组 & 干预措施

Ologen in Trabeculectomy

Experimental

Ologen in Trabeculectomy

干预措施: ologen (oculusgen) collagen matrix (Device)

MMC in Trabeculectomy

Active Comparator

MMC in Trabeculectomy

干预措施: MMC in Trabeculectomy (Drug)

结局指标

主要结局

IOP <21mmHg without anti glaucoma medication

时间窗: 180 days

次要结局

  • IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication(180-day)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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