NCT01396629已完成不适用
Clinical Evaluation of a New Cartridge for the Implantation of Foldable Intraocular Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aurolab
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- intra operative complication
研究概览
简要总结
The aim of the study is to evaluate the safety and effectiveness of a new cartridge for the implantation of foldable intraocular lenses.
详细描述
Intraocular Lenses (IOL) Cartridge is made up of polypropylene material with coating. This cartridge is used as lens delivery system for foldable lens implantation while doing cataract surgery. The coating is made up of medical grade polyurethane and biocompatible. This coating would be useful for smooth delivery of intraocular lens.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 60
- •Senile cataract
- •Nuclear Sclerosis grade I and grade II
排除标准
- •Inherent zonular weakness
- •Shallow anterior chamber
- •Traumatic cataract
- •Uveitis and Complicated cataract
- •Dense PSCC and PPC
结局指标
主要结局
intra operative complication
时间窗: post operative day 1
to asssess the incidence of cartridge related post operative complications occurring in the anterior chamber on day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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