NCT00449098Unknown4 期
Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 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 the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.
详细描述
- Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group 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 ologen (OculusGen) implant or trabeculectomy with mitomycin-C.
- 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over.
- •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 mitomycin-C or porcine collagen.
- •Subject is on warfarin and discontinuation is not recommended.
- •Normal tension glaucoma.
- •Participation in an investigational study during the 30 days preceding trabeculectomy.
- •Ocular infection within 14 days prior to trabeculectomy.
- •Pregnant or breast-feeding women.
研究组 & 干预措施
OculusGen Biodegradable Collagen Matrix Implant
Experimental
Trabeculectomy with OculusGen Biodegradable Collagen Matrix Implant
干预措施: OculusGen Biodegradable Collagen Matrix Implant (Device)
MMC
Active Comparator
Trabeculectomy with MMC
干预措施: Trabeculectomy with MMC (Drug)
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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