NCT01061918已完成4 期
Evaluation Of Bilateral Tecnis Multifocal Versus ReSTOR 3D Intraocular Lenses
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 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 intraocular lenses (IOLs) 6 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
- 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
- 否
入选标准
- •Age 18 or greater
- •Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation has been planned for both eyes
- •Visual potential of 20/30 or better in each eye after cataract removal and IOL implantation
- •Preoperative best-corrected distance visual acuity (BSDVA) worse than 20/40 Snellen. If there is a glare component, glare testing which reduces the visual acuity to less than 20/40
- •Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- •Preoperative corneal astigmatism of 1.0 D or less
- •Clear intraocular media other than cataract
- •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
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- •Subjects with diabetes mellitus
- •Uncontrolled systemic or ocular disease
- •History of ocular trauma or prior ocular surgery
- •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 20/30 or worse
- •Subjects who may be expected to require retinal laser treatment or other surgical intervention
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome)
- •Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions)
- •Contact lens usage within 6 months for polymethyl methacrylate (PMMA) contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lenses
- •Requiring an intraocular lens <15.0 or >26.0 diopters
研究组 & 干预措施
Tecnis MF
Active Comparator
干预措施: Tecnis MF (Device)
ReSTOR
Active Comparator
干预措施: ReSTOR (Device)
结局指标
主要结局
Distance Visual 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 (2)
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