A Clinical Assessment of Visual Performance of Combining the Tecnis Symfony Extended Range of Vision IOL (ZXR00) With the +3.25D Tecnis Multifocal 1-Piece IOL (ZLB00) in Subjects Undergoing Bilateral Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
This will be a single center, non comparison clinical trial. Fifty study patients will have the Symfony IOL implanted in their dominant eye and a +3,25D Tecnis Multifocal in their non-dominant eye. The investigators will be evaluated vision at distance, intermediate and near as well as assessing patient satisfaction and spectacle independence.
详细描述
Each study patient will undergo the same routine cataract extraction procedure in each eye. In their dominant eye a Tecnis Symfony IOL will be implanted and in the non dominant eye, a Tecnis +3.25D Multifocal implanted. The surgeries will be within 2 days of each other. Every patient will receive same postoperative instructions and medications. The aim is to investigate the potential benefits of implanting two different IOL's to give the patient a wider range of near vision with decreased risk of haloing and glare to enable them to be less dependent on reading glasses
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •good general health,
- •willing to comply with study instructions,
- •Visual potential of 20/30 or better,
- •less than 1.5D of corneal astigmatism,
- •normal macula,
- •clear lens or cataract,
- •pupil size greater than 3.5mm
排除标准
- •known pathology to affect visual outcome,
- •amblyopia or strabismus,
- •pupil abnormalities,
- •zonule problems,
- •keratoconus,
- •no prior ocular surgery,use of medication that could affect vision,
- •uncontrolled systemic disease
研究组 & 干预措施
Surgery Patient
All patients to be implanted bilaterally with a Tecnis Extended Range Lens in the Dominant eye and a Low Add Multifocal in the non dominant
干预措施: Cataract Surgery (Procedure)
结局指标
主要结局
Visual Acuity
时间窗: 3 months
Vision will be measured at distance, intermediate and near with and without correction.
次要结局
- Patient Satisfaction(3 months)