Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
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 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 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 Bovine 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
1
20 patients will be recruited according to the enrollment acceptance criteria.Randomisation is performed using a sealed envelope system, where 40 shuffled envelopes designating the surgery to either trabeculectomy with mitomycin-C (MMC) and trabeculectomy with ologen™ Collagen matrix must be open before surgery. Then, patients are allocated and trabeculectomy is performed.If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
干预措施: ologen collagen matrix in glaucoma filtering surgery (Device)
2
Following ethics committee approval, 20 patients with uncontrolled glaucoma will be randomised to trabeculectomy with mitomycin -C. Randomisation is performed. Then, trabeculectomy is performed
干预措施: MMC in glaucoma filtering surgery (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)