A Prospective Pilot Clinical Study of the AcrySof® IQ ReSTOR® Multifocal Toric IOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
研究概览
简要总结
The purpose of this study is to describe visual outcomes, in particular spherical equivalent by manifest refraction and visual acuity across a range of distances, 6 months post implantation of the AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL in adult patients with corneal astigmatism. Additionally, patient reported outcomes will be assessed.
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 5 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1, Month 3, and Month 6 after the second implantation). The second implantation generally occurred within 30 days of the first.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign informed consent;
- •Require cataract extraction followed by posterior IOL implantation or eligible for refractive lens exchange (RLE) in both eyes;
- •Able to undergo second eye surgery within one month (30 days) of first eye surgery;
- •Able to attend postoperative examinations per protocol schedule;
- •Qualify for a AcrySof IQ Toric IOL in both eyes;
- •Preoperative astigmatism of ≥0.75 to ≤2.5 diopters (D) in both eyes;
- •Residual refractive cylinder of ≤0.5 D in both eyes;
- •Good ocular health;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Planned multiple procedures, including LRI, during cataract/IOL implantation surgery;
- •Amblyopia;
- •Previous corneal surgery;
- •Clinically significant corneal endothelial dystrophy;
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.);
- •History of retinal detachment;
- •Pregnant or planning to become pregnant during course of 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
Best Corrected Visual Acuity (BCVA) Across a Range of Distances at Month 6
时间窗: Month 6 from second eye implantation
VA was tested binocularly with correction in place if needed across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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.
Proportion of Subjects That Achieved Spherical Equivalent Within ± 0.5D, ± 0.75D, and ± 1.0D at Month 6
时间窗: Month 6 from second eye implantation
Manifest refraction was performed under well-lit conditions using an ETDRS chart. The subject was manually refracted to his/her best correction by an outcomes assessor using a phoropter or trial lenses. Manifest refraction was performed for each eye. Proportion of subjects that achieved spherical equivalent within ± 0.5D/ ± 0.75D/ ± 1.0D at Month 6 is reported as percentage of subjects.
Uncorrected Visual Acuity Across a Range of Distances at Month 6
时间窗: Month 6 from second eye implantation
Visual acuity (VA) was tested binocularly (both eyes together) unaided across a range of distances under well-lit conditions using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts. VA 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
- Patient Reported Outcomes at Month 6(Month 6 from second eye implantation)