A Prospective Randomized Comparative Study of the Safety and Effectiveness of Ologen Collagen Matrix Versus Mitomycin-C in Trabeculectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP) reduction
研究概览
简要总结
The aim of this prospective randomized study is to investigate the efficacy and safety of trabeculectomy with ologen Collagen Matrix versus trabeculectomy using mitomycin C (MMC) in patients with medically uncontrolled open angle glaucoma.
详细描述
ologen® Collagen Matrix (CM) is an artificial extracellular matrix (ECM) specifically configured to support repair in connective and epithelial ocular tissue. The device is constructed so as to minimize random growth of fibroblasts and instead to allow them to grow through the pores in the matrix. ologen® CM is a biodegradable scaffold matrix, inducing a regenerative non-scarring wound healing process without using anti-fibrotic agents. For application in glaucoma filtration surgery, ologen® CM is designed to prevent scar formation (subconjunctival and scleral flap scarring is the major risk factor for failure of trabeculectomy). After implanting the ologen® CM on top of the scleral flap in the subconjunctival space, a functional bleb can be created.
The aim of the present study is to determine the effectiveness of the ologen® CM and reduce wound scarring, thereby increasing success of trabeculectomy without side effects of MMC. A means of producing better success rate and reduced complications is the purpose of ologen® Collagen Matrix for the aid of glaucoma surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 open-angle glaucoma
- •Subject is willing to sign informed consent
- •Subject is able and willing to complete post-operative follow-up requirements
排除标准
- •Inflammatory eye diseases
- •Angle-closure glaucoma
- •Secondary glaucoma with anatomical malformations of the eye
- •Subjects having single functional eye
- •Previous conjunctival surgery
- •Known allergic reactions to ingredients of ologen Collagen Matrix
- •Excessive myopia (axial length (AL)> 27 mm or more than -10 diopters)
- •Previous vitrectomy eye surgery
- •Subjects do not consent to participate
研究组 & 干预措施
ologen Collagen Matrix
干预措施: Use of ologen Collagen Matrix in trabeculectomy (Device)
Mitomycin-C (MMC)
干预措施: Use of Mitomycin-C in trabeculectomy (Drug)
结局指标
主要结局
Intraocular pressure (IOP) reduction
时间窗: 6 months
次要结局
- Incidence of complications(6 months)