NCT01275118已完成4 期
Comparative Study of Photopic and Mesopic Distance, Intermediate and Near Visual Acuity, and Spectacle Independence With Bilateral Implantation of the Tecnis Multifocal (TMF) Intraocular Lens or Crystalens AO (CAO) Intraocular Lens
Mark Packer, MD, FACS2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2010年12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
- 26
- 试验地点
- 2
- 主要终点
- Visual function
研究概览
简要总结
Comparison of postoperative visual acuity and spectacle independence between the Tecnis Multifocal Intraoculer Lens (IOL) and the crystalens Accommodating IOL
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
- •Status post bilateral cataract or refractive lens surgery (with or without LRI) and implantation of Tecnis™ Multifocal IOL or Crystalens™ AO Accommodating IOL
- •Best-corrected ETDRS equivalent visual acuity of 20/30 or better in each eye
- •Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes
- •Clear intraocular media (no posterior capsular opacification, or status post YAG capsulotomy)
- •Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
排除标准
- •Ocular disease which could potentially limit uncorrected visual acuity or visual performance.
- •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
- •History of ocular surgery other than that required for inclusion in this study
- •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)
结局指标
主要结局
Visual function
时间窗: 3 months postoperatively
次要结局
- Use of spectacle correction and vision-related quality of life(3 months postoperatively)
研究者
Mark Packer, MD, FACS
Sponsor-Investigator
Drs. Fine, Hoffman and Packer, LLC
研究点 (2)
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