A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
研究概览
简要总结
The purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.
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 an informed consent;
- •Willing and able to attend post-operative examinations per protocol schedule;
- •In good ocular health, with the exception of cataracts;
- •Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
- •Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
- •In good ocular health, with the exception of cataracts;
- •Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Previous corneal surgery;
- •Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
- •Planned multiple procedures during cataract/IOL implantation surgery;
- •Ocular disease and/or condition that may compromise study results;
- •Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
- •Pregnant or planning pregnancy during course of study;
- •Participation in any other investigational study within 30 days prior to enrolment;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
时间窗: Month 3
Uncorrected visual acuity (i.e., visual acuity measured without spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study charts at 100% contrast and measured in logarithm of the minimum angle of resolution (logMAR). Each eye was assessed, and both eyes contributed to the mean. LogMAR 0.00 is equivalent of 20/20 and LogMAR 1.0 is equivalent of 20/200. A more negative logMAR value would indicate a greater improvement in visual acuity.
次要结局
未报告次要终点