NCT01074606终止4 期
Visual Function After Implantation of AcrySof® Toric Lens
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Postoperative Refractive Cylinder
研究概览
简要总结
The objective of this study is to evaluate the postoperative visual function of Taiwanese patients following bilateral or unilateral AcrySof Toric Intraocular Lens (IOL) implantation.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective subjects should be adults and may be of any race and gender, and diagnosed with cataracts.
- •Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens.
- •All subjects must have between 0.75 - 2.0 Diopter (D) of astigmatism preoperatively as measured by keratometry readings.
- •For any second eye surgery in bilateral AcrySof Toric patients, it should be performed at least one week following the first eye implant but no longer than one month after the first implant.
排除标准
- •Subjects with pre-existing conditions that could skew the results should be excluded from the Study.
- •AcrySof® Toric product inserts under "Precautions" for subject groups that should be excluded from this Study.
结局指标
主要结局
Postoperative Refractive Cylinder
时间窗: Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative
次要结局
- Uncorrected distance visual acuity (UCDVA)(Pre-Operative Day, 1 Month Postoperative, 3 Month Postoperative)
- Best corrected distance visual acuity (BDCVA)(Pre-operative, 1 month postoperative, 3 months postoperative)
研究者
研究点 (1)
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