NCT00760058撤回4 期
Visual Outcome and Visual Quality After Bilateral Implantation of the AcrySof® IQ IOL Compared to MI60® and Tecnis® IOL
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Contrast sensitivity
研究概览
简要总结
The objective of the study is to compare the visual outcomes of three aspheric monofocal intraocular lenses after cataract surgery - ACRYSOF® IQ, Tecnis® and Akreos® MI60.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, aged 50 and over.
- •Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
- •Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
- •Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
- •Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.
排除标准
- •Subjects who have previously had corneal surgery.
- •Subjects who have potential visual acuity which is < 6/12 due to other ocular pathology
- •Subjects with corneal pathology.
- •Subjects with astigmatism of greater than 1D.
- •Subjects diagnosed with glaucoma.
- •Subjects diagnosed with diabetes.
- •Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
- •Subjects with a know history of poor compliance
- •Subjects with planned adjunctive surgery
研究组 & 干预措施
1
Experimental
AcrySof® IQ intraocular lens
干预措施: AcrySof® IQ IOL (Device)
2
Active Comparator
Tecnis® Aspheric intraocular lens
干预措施: Tecnis® Aspheric intraocular lens (Device)
3
Active Comparator
Akreos® MI60 intraocular lens
干预措施: Akreos® MI60 intraocular lens (Device)
结局指标
主要结局
Contrast sensitivity
时间窗: 3 months
次要结局
- Visual acuity, contrast acuity, wavefront analysis, corneal spherical aberration, manifest refraction.(3 months)
研究者
研究点 (1)
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