A Comparative Pilot Study Of High-Order Aberrations With Aspheric Intraocular Lens (IOL) Models SN60WF And ZCB00
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total ocular high-order aberrations
研究概览
简要总结
The purpose of this study was to prospectively compare high-order aberrations between eyes implanted with the AcrySof® Natural IQ (SN60WF) intraocular lens (IOL) versus those implanted with the Tecnis ZCB00 IOL.
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
- •Requires bilateral extraction of cataracts by phacoemulsification followed by implantation of a posterior chamber intraocular lens;
- •Confirmed absence of pre-existing conditions that could skew the results or present contraindications for the IQ intraocular lens (IOL) or the Tecnis ZCB00 IOL;
- •<1 diopter corneal astigmatism preoperatively;
- •Able to achieve 6.5 mm dilated pupil;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Chronic disease or illness;
- •Irregular optical aberration;
- •Amblyopia;
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
- •Diabetic retinopathy;
- •Macular degeneration;
- •History of retinal detachment;
- •Other surgeries planned at time of cataract removal;
- •Severe dry eye;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
ZCB00 IOL
Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens (IOL) randomly assigned to one eye, with AcrySof Natural IQ (SN60WF) IOL in the fellow eye for contralateral implantation
干预措施: Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL (Device)
SN60WF IOL
AcrySof Natural IQ (SN60WF) intraocular lens (IOL) randomly assigned to one eye, with Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens in the fellow eye for contralateral implantation
干预措施: AcrySof Natural IQ (SN60WF) IOL (Device)
结局指标
主要结局
Total ocular high-order aberrations
时间窗: Month 1 postoperative
次要结局
未报告次要终点