A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 21
- 主要终点
- Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
研究概览
简要总结
The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.
详细描述
Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
- •Diagnosed with cataract in both eyes;
- •Planned cataract removal by routine small incision surgery;
- •Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
- •Preoperative regular astigmatism of less than 1.0 D.
排除标准
- •Pregnancy or lactation current or planned during the course of the study;
- •History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.
研究组 & 干预措施
DFT015
ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
干预措施: Cataract surgery (Procedure)
DFT015
ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation
干预措施: ACRYSOF® IQ Extended Depth of Focus IOL (Device)
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
干预措施: ACRYSOF® IQ Monofocal IOL (Device)
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
干预措施: Cataract surgery (Procedure)
结局指标
主要结局
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)
时间窗: Month 3 (70-100 days post second eye implantation)
Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Percentage of Subjects With Ocular Adverse Events
时间窗: Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
次要结局
- Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)(Month 3 (70-100 days post second eye implantation))
- Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm(Month 3 (70-100 days post second eye implantation))
- Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve(Month 3 (70-100 days post second eye implantation))
- Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)(Month 6 (120-180 days post second eye implantation))
- Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"(Month 6 (120-180 days post second eye implantation))
- Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"(Month 6 (120-180 days post second eye implantation))