ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
研究概览
简要总结
Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.
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
- •Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts
- •Calculated lens power is within the available range
- •Willing and able to complete all required postoperative visits
- •Planned cataract removal by phacoemulsification and/or liquifacture
- •Potential postoperative visual acuity of 0.2 logMAR or better in study eyes
- •Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes
- •Clear intraocular media other than cataract in study eyes
- •Able to comprehend and sign a statement of informed consent
- •Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on "Medium" setting must be worse than 0.2 logMAR
排除标准
- •Significant irregular corneal aberration as demonstrated by corneal topography
- •Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR
- •Subjects who may reasonably be expected to require laser treatments at any time
- •Previous corneal refractive surgery
- •Amblyopia
- •Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)
- •Diabetic retinopathy
- •Extremely shallow anterior chamber, not due to swollen cataract
- •Microphthalmos
- •Previous retinal detachment
- •Previous corneal transplant
- •Recurrent severe anterior or posterior segment inflammation of unknown etiology
- •Rubella or traumatic cataract
- •Iris neovascularization
- •Glaucoma (uncontrolled or controlled with medication)
- •Optic nerve atrophy
- •Pregnancy
- •Current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g.Flomax® (tamsulosin HCL), Hytrin®, or Cardura®)
- •Any subject currently participating in another investigational drug or device study that may confound the results of this investigation
研究组 & 干预措施
ReSTOR Aspheric +3.0D
ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens
干预措施: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (Device)
ReSTOR Aspheric +4.0D
ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
干预措施: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens (Device)
结局指标
主要结局
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
时间窗: 3 months
Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.
次要结局
- Binocular Distance Corrected Distance Visual Acuity(3 months post-operative)
- Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)(3 months post-operative)
- Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)(3 months post-operative)
- Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)(3 months post-operative)