NCT01383057已完成4 期
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
- •Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.
- •The surgeon may use the Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.
排除标准
- •Concurrent participation or participation in the last thirty days in any other clinical trial.
- •Known steroid IOP responder
- •Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, etc.)
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
- •Uncontrolled systemic or ocular disease
- •Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
- •Pseudoexfoliation
- •Ocular hypertension IOP >25 mmHg by tonometry or glaucomatous changes in the optic nerve
研究组 & 干预措施
Femtosecond Laser
Experimental
干预措施: Femtosecond Laser (Procedure)
结局指标
主要结局
Intraocular Pressure
时间窗: 3 months
Measure the fluid pressure inside the eye
Uncorrected and Best corrected Visual Acuity
时间窗: one month
Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).
次要结局
未报告次要终点
研究者
研究点 (1)
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