Clinical Outcomes After Implantation of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (MIOL) in the Dominant Eye and Randomization of the AcrySof® IQ ReSTOR® +2.5 D or +3.0 D MIOL in the Fellow Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
研究概览
简要总结
The purpose of this study is to compare AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in both eyes (bilateral implantation) to AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL in the dominant eye with AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL in the fellow eye (contralateral implantation) at Month 3 following the second eye surgery.
详细描述
Each subject will complete a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Day 30 and Day 90 after the second implantation). The second implantation will occur between 1 and 45 days of the first. If the first eye is not implanted during surgery, the second eye is not eligible. lf both eyes are not implanted with the assigned IOL, the subject will be followed for safety evaluation.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to understand and sign informed consent, and attend postoperative examinations per protocol schedule;
- •Requires cataract extraction followed by posterior intraocular lens implantation used as an on-label procedure in both eyes;
- •Willing to have second eye surgery within 45 days of first eye surgery;
- •Expected postoperative astigmatism < 1.0 D in both eyes, as measured by keratometry;
- •Free of severe diseases(s)/condition(s) listed in the Warnings and Precautions section of the package inserts;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Refractive lens exchange (monocular DCVA of worse than 20/20, or ≥ 0.06 logMAR). This exclusion did not apply to binocular (OU) measurement;
- •Significant irregular corneal astigmatism as demonstrated by corneal topography;
- •Severe degenerative visual disorders;
- •Previous corneal surgery;
- •Amblyopia;
- •Planned multiple procedures, including LRI, LASIK, etc, during surgery or the course of the study;
- •History of corneal disease;
- •Severe diabetic retinopathy;
- •History of retinal detachment;
- •Severe conditions or acute or chronic diseases or illnesses that, per investigator's clinical judgment, would increase the operative risk or confound the results of the study;
- •Pregnant or planning pregnancy during course of study;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)
时间窗: Day 90 from second eye implantation
Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.
次要结局
- Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)(Day 90 from second eye implantation)