Trabeculectomy With Ologen-Pilot
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Postoperative intraocular pressure level
研究概览
简要总结
Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis.
Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.
This is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared.
The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication.
- •Indication for trabeculectomy with mitomycin-C
排除标准
- •Unability to discontinue oral anticoagulants
- •Difficulty in reading or speaking Dutch
- •Previous ocular surgery (cataract surgery allowed)
- •Pregnant and breastfeeding women
结局指标
主要结局
Postoperative intraocular pressure level
时间窗: 3 months
次要结局
- Number of glaucoma medications(3 months)
研究者
Henny Beckers
MD, PhD, Ophthalmologist
Maastricht University Medical Center
