Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Monocular Uncorrected Distance Decimal Visual Acuity
研究概览
简要总结
The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients.
详细描述
Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent;
- •Diagnosed with bilateral cataracts;
- •Planned cataract removal by phacoemulsification;
- •Potential postoperative visual acuity of 0.6 decimal or better in both eyes;
- •Preoperative astigmatism ≥ 0.75 diopter;
- •Clear intraocular media other than cataract in study eyes;
- •Calculated lens power and astigmatism within the available range;
- •Pupil size greater than or equal to 6 mm after dilation;
- •Able to undergo second eye surgery within 30 days of the first eye surgery;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Irregular corneal aberration as demonstrated by corneal topography;
- •Any inflammation or edema (swelling) of the cornea;
- •Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.6 decimal;
- •Diabetic retinopathy;
- •Previous refractive surgery, retinal detachment, corneal transplant;
- •Glaucoma;
- •Pregnant, nursing, or suspected of being pregnant;
- •Currently participating in another investigational drug or device study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
ReSTOR +3.0
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
干预措施: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL (Device)
结局指标
主要结局
Monocular Uncorrected Distance Decimal Visual Acuity
时间窗: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Monocular Uncorrected Near Decimal VA
时间窗: Day 30-60, Day 120-180, Day 330-420
VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
次要结局
未报告次要终点