NCT00999492已完成4 期
Selection of Aspheric Diffractive Multifocal IOLS Based on Corneal Wavefront
Mark Packer, MD, FACS1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2009年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Frequency of spectacle wear
研究概览
简要总结
Given the availability of aspheric diffractive IOLs with varying negative spherical aberration it may be feasible, by selecting the best fit IOL, to minimize aberrations and thereby maximize visual performance.
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
- 否
入选标准
- •18 years of age or older
- •Scheduled to undergo bilateral cataract or refractive lens surgery
- •Visual potential of 20/30 or better in each eye after lens removal and IOL implantation
- •Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- •Preoperative regular corneal astigmatism of 2.5 D or less
- •Clear intraocular media other than cataract
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
排除标准
- •Ocular disease other than cataract which could potentially limit uncorrected visual acuity or visual performance.
- •Astigmatism not correctable by limbal relaxing incisions (greater than 2.5 D)
- •Use of systemic or ocular medications that may affect visual outcomes
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.)
- •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 worse than 20/30
- •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 or abnormally shaped pupils)
- •Contact lens usage within 6 months for PMMA lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft lenses
- •Requiring an intraocular lens power <15.0 or >26.0 diopters
结局指标
主要结局
Frequency of spectacle wear
时间窗: 3 months postoperatively
次要结局
- Frequency and degree of visual symptoms(3 months postoperatively)
研究者
Mark Packer, MD, FACS
Sponsor-Investigator
Drs. Fine, Hoffman and Packer, LLC
研究点 (1)
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