NCT01278420Unknown4 期
AMO's Tecnis™ Multifocal Intraocular Lenses (Tecnis MF), Alcon's ReStor Multifocal IOL
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Distance Visual Acuities
研究概览
简要总结
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
详细描述
The purpose of this study is to compare the visual outcomes with bilateral implantation of Tecnis MF and ReSTOR IOLs Six months post cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or greater
- •Bilateral condition (cataracts or Presbyopia) for which phacoemulsification and posterior IOL implantation has been planned for both eyes
- •Visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
- •Clear intraocular media other than cataract
- •Normal OCT of the macula
- •No evidence of Keratoconus or significant irregular astigmatism on Preoperative topography
- •No evidence of Epithelial Basement Membrane Dystrophy on Slit lamp Exam
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
排除标准
- •Use of systemic or ocular medications that may affect vision
- •Uncontrolled systemic or ocular disease
- •History of ocular trauma
- •History of intraocular, extraocular Muscle, or corneal surgery (including laser vision correction)
- •Amblyopia or strabismus
- •Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
- •Diagnosed degenerative visual disorders (e.g. macular degeneration, or other retinal disorders) that are predicted to cause future acuity losses to a level of 20/25 or worse
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention (i.e patients with diabetic retinopathy)
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Contact lens usage within 2 months for PMMA contacts lenses, 2 weeks for gas permeable lenses or 3 days for extended-wear and daily-wear soft contact lenses
结局指标
主要结局
Distance Visual Acuities
时间窗: 1 year
Near Visual Acuities
时间窗: 1 year
Intermediate Acuities
时间窗: 1 year
Refraction
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (12)
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