A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Corneal Aberration
研究概览
简要总结
The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular criteria must be met in both eyes.
- •Willing and able to understand and sign an informed consent;
- •Willing and able to attend postoperative examinations per protocol schedule;
- •Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;
- •Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;
- •Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;
- •Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Previous corneal surgery;
- •Planned multiple procedures during cataract/IOL implantation surgery;
- •Ocular disease and/or condition that may compromise study results;
- •Pregnant or planning pregnancy during course of study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
IQ Toric IOL
AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation.
干预措施: AcrySof IQ Toric IOL (Device)
IQ Aspheric IOL + LRI
AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation
干预措施: AcrySof IQ Aspheric IOL (Device)
IQ Aspheric IOL + LRI
AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation
干预措施: Limbal Relaxing Incision (LRI) (Procedure)
结局指标
主要结局
Corneal Aberration
时间窗: Month 6 postoperative
次要结局
- Visual Acuity(Month 6 postoperative)
- Corneal Cylinder(6 months)