NCT00448929已完成3 期
Comparative Study of the Safety and Effectiveness Between Trabeculectomy and Trabeculectomy With Ologen (OculusGen) Collagen Matrix Implant
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the effectiveness via the reduction of IOP
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of trabeculectomy with ologen (OculusGen) Biodegradable Collagen Matrix Implant and trabeculectomy without antifibrotic agents.
详细描述
- Study Objective: To determine the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
- Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy without antifibrotics.
- Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30 years or over.
- •No previous intraocular operative surgery
- •Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
- •Subject able and willing to cooperate with investigation plan.
- •Subject able and willing to complete postoperative follow-up requirements.
- •Subject willing to sign informed consent form.
排除标准
- •Known allergic reaction to porcine collagen.
- •Subject is on warfarin and discontinuation is not recommended.
- •Patient who has been diagnosed for one of following glaucoma: normal tension glaucoma, uveitic glaucoma, aphakia or pseudophakia glaucoma, neovascular glaucoma and other classified secondary glaucoma.
- •Participation in an investigational study during the 30 days proceeding trabeculectomy.
- •Ocular infection within 14 days prior to trabeculectomy.
- •Pregnant or breast-feeding women
研究组 & 干预措施
Trabeculectomy with Oculusgen
Experimental
干预措施: OculusGen Biodegradable Collagen Matrix Implant (Device)
Trabeculectomy without Oculusgen or antifibrotic agents
No Intervention
结局指标
主要结局
the effectiveness via the reduction of IOP
时间窗: 180 day
次要结局
- the safety via the incidence of complications and adverse events.(180 day)
研究者
研究点 (1)
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