NCT01249144终止4 期
A Randomized Fellow-eye Controlled Clinical Trial to Compare the Visual and Refractive Outcomes Between Two Aspheric IOLs With Different Dioptric Increments and Manufacturing Tolerances in Patients Undergoing Bilateral Cataract Surgery
Lenstec Incorporated2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Target versus Achieved Refraction
研究概览
简要总结
This study compares two intraocular lenses, the Softec HD and the Tecnis Z9002, used to replace the natural crystalline lens after cataract extraction. The variables compared include 1) the accuracy of targeted versus achieved refractive outcomes and 2) visual acuity outcomes three months after implantation.
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
- Double (Participant, Outcomes Assessor)
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
- •operable cataracts in both eyes
- •require intraocular lenses (IOLs) in dioptric range from 18.0 diopters to 25.0 diopters in both eyes
- •</=1 diopter (D) of regular astigmatism in both eyes
排除标准
- •Intraocular surgery or laser treatment prior to cataract surgery
- •Severe dry eye
- •Presence of ocular infection
- •Uncontrolled intraocular pressure (IOP) or glaucoma preventing a postoperative best corrected visual acuity (BCVA) of 20/25 Snellen or better
- •Retinal or macular pathology preventing a postoperative BCVA of 20/25 Snellen or better
- •History of retinal detachment
- •Corneal decompensation
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- •Clinically significant corneal endothelial dystrophy (e.g., Fuchs' dystrophy)
- •Amblyopia preventing a postoperative BCVA of 20/25 Snellen or better
结局指标
主要结局
Target versus Achieved Refraction
时间窗: 3 Months Postoperative
次要结局
- Uncorrected Visual Acuity(3 Months Postoperative)
研究者
研究点 (2)
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