Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary endpoint is to prove the effectiveness via the reduction of IOP.
研究概览
简要总结
The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy 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.
详细描述
Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy)
Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed
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
- 否
入选标准
- •Age 18 years or over.
- •At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
- •Visually significant cataract with visual acuity of less than or equal to 6/
- •Subject able and willing to cooperate with investigation plan.
- •Subject willing to sign informed consent form.
排除标准
- •Known allergic reaction to collagen.
- •Subject is on Warfarin and discontinuation is not recommended.
- •Subject with normal tension glaucoma or aphakic glaucoma.
- •Subject with corneal disease.
- •Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
- •Ocular infection within 14 days prior to phacotrabeculectomy.
- •Pregnant or breast-feeding women.
- •Monocular subject.
结局指标
主要结局
The primary endpoint is to prove the effectiveness via the reduction of IOP.
时间窗: 180 days
次要结局
- the secondary endpoint is to prove the safety via the reduction of complications.(180 days)