A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Mean Binocular Defocus VA at Month 3
研究概览
简要总结
The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.
详细描述
Each subject completed 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 Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.
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
- •Sign informed consent;
- •Able to attend postoperative examinations per protocol schedule;
- •Diagnosed with bilateral cataracts;
- •Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
- •Preoperative astigmatism ≤ 2.5 diopter;
- •Good ocular health, with the exception of cataracts;
- •Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
- •Able to undergo second eye surgery within one month of the first eye surgery;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Previous corneal surgery;
- •Planned multiple procedures during cataract/IOL implantation surgery;
- •Any ocular disease and/or condition that may compromise study results;
- •Pregnant or planning pregnancy during course of study;
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- •Diabetic retinopathy;
- •Macular degeneration;
- •History of retinal detachment;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
干预措施: AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 (Device)
ReSTOR +3
AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
干预措施: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT (Device)
Acri.LISA
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
干预措施: Acri.LISA® 366D IOL (Device)
Acri.LISA
Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
干预措施: Acri.LISA® 466TD Toric IOL (Device)
结局指标
主要结局
Mean Binocular Defocus VA at Month 3
时间窗: Month 3 from second eye implantation
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.
次要结局
- Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 3(Month 3 from second eye implantation)
- Uncorrected Visual Acuity Across a Range of Distances at Month 3(Month 3 from second eye implantation)
- Mean Refractive Spherical Equivalent at Month 3(Month 3 from second eye implantation)
- Mean Radner Reading Speed(Month 3 from second eye implantation)
- Patient Reported Outcomes at Month 3(Month 3 from second eye implantation)