NCT01014702Unknown2 期
Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity
LensAR Incorporated1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Completeness and ease of opening of capsulotomy
研究概览
简要总结
The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must sign and be given a copy of the written informed consent form
- •Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
- •Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
- •Subjects must have central 7 mm of clear cornea without vascularization.
排除标准
- •Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
- •Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
- •Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
- •Subjects with macular degenerative pathology.
- •Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
- •Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- •Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
结局指标
主要结局
Completeness and ease of opening of capsulotomy
时间窗: Day 0 (Surgery)
Reduced need for ultrasound phacoemulsification compared to control eye
时间窗: Day 0 (surgery)
Rate of adverse events
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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