NCT01382823已完成4 期
Laser Cataract Surgery With the Femtosecond Laser Technology
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 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 Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity.
排除标准
- •Concurrent participation or participation in the last 30 days in other clinical trials.
- •Known steroid IOP responder.
- •Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, 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 (>or =20hg) or glaucomatous changes in the optic nerve.
结局指标
主要结局
Intraocular Pressure
时间窗: three month
Measure the fluid pressure inside the eye.
Uncorrected and Best corrected Visual Acuity
时间窗: three 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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