A Prospective Multicenter Clinical Trial To Evaluate the Effectiveness of A Toric Accommodating Posterior Chamber Silicone Intraocular Lens Designed To Provide Near, Intermediate, And Distance Vision And Reduce The Effects Of Preoperative Corneal Astigmatism On Postoperative Refraction Following Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 2
- 主要终点
- Percent Reduction in Absolute Cylinder
研究概览
简要总结
The objective of this clinical trial is to evaluate the safety and effectiveness of the Bausch + Lomb Toric Accommodating Posterior Chamber Silicone Intraocular Lens used to provide near, intermediate, and distance vision and a reduction of the effects of preoperative corneal astigmatism in presbyopic patients undergoing cataract extraction and intraocular lens (IOL) placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Subjects must have a clinically documented diagnosis of age-related cataract
- •Subjects must require a lens power from 16 to 27 diopters
- •Subjects must have predicted post-operative corneal astigmatism between 0.83D and 2.50D, as determined by the Toric Calculator
排除标准
- •Subjects with any anterior segment pathology for which extracapsular/ phacoemulsification cataract surgery would be contraindicated.
- •Subjects with diagnoses of degenerative visual disorders.
- •Subjects with conditions associated with increased risk of zonular rupture.
- •Subjects who have had previous corneal surgery in the planned operative eye.
- •Subjects with irregular corneal astigmatism.
- •Subjects with clinically significant retinal pigment or epithelium/macular changes.
- •Subjects with chronic use of systemic steroids or immunosuppressive medications.
- •Subjects either concurrently participating in another clinical trial or have participated in another clinical trial within 60 days prior to enrollment in this study.
- •Subjects with a difference in corneal astigmatism measured with the IOL Master and the topographer greater than 0.5 D using vector analysis.
结局指标
主要结局
Percent Reduction in Absolute Cylinder
时间窗: 120 - 180 day postoperative visit
Percent reduction in absolute cylinder expressed as a percentage of the intended reduction in cylinder. Cylinder reduction is the measurement for astigmatism reduction. Astigmatism is a form of refractive error that can affect uncorrected visual acuity (at all distances). Reducing cylinder should improve UCVA, but other elements of refractive error, such as myopia or hyperopia, can also affect UCVA. Best corrected visual acuity (BCVA) is not affected by refractive error.
次要结局
- Lens Misalignment(120 - 180 day postoperative visit)
- Visual Acuity(120 - 180 day postoperative visit)