跳至主要内容
临床试验/NCT01753492
NCT01753492终止不适用

Trabeculectomy With Ologen-Pilot

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henny Beckers

MD, PhD, Ophthalmologist

Maastricht University Medical Center

研究点 (2)

Loading locations...

相似试验