NCT01299155已完成不适用
A Randomized, Pilot Study, Subject Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses (IOLs)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Unilateral Uncorrected Near Visual Acuity
研究概览
简要总结
To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (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
- •are willing and able to understand and sign an informed consent
- •<= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure "regular" astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements.
- •are willing and able to attend postoperative examinations per protocol schedule
- •are more than 21 years of age, of either gender and any race:
- •require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure
- •be willing to have second eye surgery within one month of first eye surgery
- •are in good ocular health, with the exception of cataracts
- •are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof IQ ReSTOR +3 and LENTIS Mplus package inserts
- •are able to read and understand one of the following languages: Dutch or Spanish
排除标准
- •Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery
- •An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.)
- •Previous corneal surgery and/or reshaping
- •Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy)
- •History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.)
- •History of retinal detachment
- •Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (eg, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness).
- •suturing of incision required at time of surgery
结局指标
主要结局
Unilateral Uncorrected Near Visual Acuity
时间窗: 3 months after surgery
次要结局
未报告次要终点
研究者
研究点 (2)
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