NCT02016898已完成2 期
The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complication Rates
研究概览
简要总结
The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.
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
- Double (Participant, Investigator)
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
- •Men or women aged 18 years and older at screening.
- •Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma.
- •Suitable candidate for trabeculectomy with Ex-PRESS glaucoma filtration device with MMC in the superonasal quadrant in the study eye which the physician deems as medically necessary.
- •Capable and willing to provide consent
排除标准
- •Unable or unwilling to provide consent
- •Any previous ocular surgeries in the study eye preventing placement of the trabeculectomy with Ex-PRESS glaucoma filtration device with mitomycin-C in the superonasal quadrant
- •Any previous glaucoma drainage devices in the study eye
- •Any abnormality other than glaucoma in the study eye that could affect applanation tonometry.
- •Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
- •Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day
- •Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •Known Pregnancy or Breastfeeding
- •Physical and Laboratory Findings
- •Conjunctival scarring precluding a superonasal implantation location.
- •Vitreous in the anterior chamber.
- •Abnormality preventing reliable applanation tonometry in the study eye.
研究组 & 干预措施
Sponge placement of Mitomycin-C
Experimental
Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.
干预措施: Placement of the sponge (Procedure)
Sponge placement of Mitomycin-C
Experimental
Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.
干预措施: Mitomycin-C (Drug)
Irrigation placement of Mitomycin-C
Experimental
Randomization will be stratified by age (age ≥65 or age < 65), baseline IOP (IOP ≥ 28 mmHg or IOP < 28 mmHg), and concurrent cataract surgery.
干预措施: Mitomycin-C (Drug)
结局指标
主要结局
Complication Rates
时间窗: post-operative day 1 to month 6
To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation
次要结局
- Change in Intraocular Pressure(post-operative day 1 to month 6)
研究者
研究点 (1)
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