NCT00959322已完成不适用
A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
LenSx Lasers Inc.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Capsulotomy is complete
研究概览
简要总结
The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in the anterior surface of the capsular bag that contains the cataractous crystalline lens. The objective of this study is to evaluate the ability of the LenSx 550 laser to successfully perform anterior capsulotomy during cataract surgery.
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
- 24 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
- •Must be at least 24 years of age.
- •Must be willing and able to return for scheduled follow-up examinations.
- •Subjects must sign and be given a copy of the written Informed Consent form.
排除标准
- •Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
- •Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
- •Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded.
- •History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>21 mm Hg in either eye.
- •Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- •Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- •Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
- •Known sensitivity to planned study concomitant medications.
- •Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
- •Subjects presenting any contraindications to cataract surgery.
结局指标
主要结局
Capsulotomy is complete
时间窗: 1 day, 1 week, 1 month
次要结局
- No radial tears noted intraoperatively(1 day, 1 week, 1 month)
研究者
研究点 (2)
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