Phacotrabeculectomy With Collagen Matrix Implant (Ologen®) Versus Mitomycin C Augmented Phacotrabeculectomy: Clinical Results of a Prospective Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Mean intraocular pressure (IOP) after the surgery
研究概览
简要总结
- Study objective: To assess the efficacy and safety of collagen matrix implant (Ologen®; OLO) in phacotrabeculectomy and to compare with mitomycin C (MMC) augmented phacotrabeculectomy.
- Study Design: The study is designed as a prospective randomized trial. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study.
- Follow-Up: This investigation is including 7 post-operative visits and follow-up within 12 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 30, 90, 180, 270 and 360.
详细描述
- Prospective randomized comparative study
- Patients with cataract and:
primary open angle glaucoma (POAG) pseudoexfoliation (PEX) glaucoma (PEXG)
- Phacotrabeculectomy augmented with OLO or MMC
- Follow-up - 12 months
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
- 是
入选标准
- •Primary open angle glaucoma or pseudoexfoliation glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication
排除标准
- •Difficulty in reading or speaking Polish
- •Previous ocular surgery
- •Pregnant and breastfeeding women
- •Angle closure glaucoma
- •Secondary glaucoma except pseudoexfoliation glaucoma
- •Ocular diseases with excessive scarring
- •Allergy to collagen or Mitomycin C
研究组 & 干预措施
Ologen (OLO)
Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy
干预措施: Ologen (Device)
Ologen (OLO)
Ologen implant (model 830601) placed over scleral flap during phacotrabeculectomy
干预措施: Phacotrabeculectomy (Procedure)
Mitomycin C (MMC)
Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)
干预措施: Phacotrabeculectomy (Procedure)
Mitomycin C (MMC)
Mitomycin C (MMC) 0.3 mg/ml for 3 minutes under the scleral flap during phacotrabeculectomy (standard procedure)
干预措施: Mitomycin C (Drug)
结局指标
主要结局
Mean intraocular pressure (IOP) after the surgery
时间窗: 12 months
Decrease in IOP before and after the surgery
次要结局
- Mean best corrected visual acuity (BCVA) (LogMAR)(12 months)
- Evaluation of the filtering bleb in MBGS (Moorfields Bleb Grading System)(12 months)
- Mean number of antiglaucoma medications(12 months)
研究者
Aleksandra Wlaz
PhD, ophthalmologist in Department of Diagnostics and Microsurgery of Glaucoma
Medical University of Lublin