NCT00972621已完成不适用
Clinical Evaluation of a New Viscoelastic for Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material.
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, Outcomes Assessor)
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
- •Otherwise healthy eye with no pathology other than the presence of cataract
- •Visual potential of 20/40 or better
排除标准
- •Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
- •Known intraocular pressure increases from steroid treatment
- •Low endothelial cell count
研究组 & 干预措施
Vitrax II
Experimental
Investigational dispersive viscoelastic
干预措施: Vitrax II (Device)
Viscoat
Active Comparator
Marketed control dispersive viscoelastic
干预措施: Viscoat (Device)
结局指标
主要结局
Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively
时间窗: 3 months postoperative
Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.
次要结局
- Postoperative Mean Endothelial Cell Count(3 months postoperative)
研究者
研究点 (2)
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