A Three Arm Prospective Clinical Evaluation of Three FDA Approved Intraocular Lenses Designed to Improve Distance, Intermediate and Near Vision Following Lens Extraction.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
研究概览
简要总结
The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
- •Subjects must require a spherical lens power from 10.00 D to 33.00 D
- •Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter
排除标准
- •Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
- •Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
- •Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
结局指标
主要结局
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 and 3 Cycles/Degree
时间窗: Postoperative visit 3 (2-3 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 6 Cycles/Degree
时间窗: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 12 Cycles/Degree
时间窗: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 18 Cycles/Degree
时间窗: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 1.5 Cycles/Degree
时间窗: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
Mesopic Monocular Contrast Sensitivity Without Glare 3 Cycles/Degree
时间窗: Postoperative visit 4 ( 4-6 months)
Logarithm of the mesopic (low light) contrast sensitivity (ability to detect detail with subtle gradations of grayness between test target and background) without glare at five spatial frequencies (number of light and dark bars per cycle). A higher mean indicates improved contrast sensitivity
次要结局
- Monocular Halo and Starburst(Visit 4 (4-6 months))
- Binocular Halo and Starburst(Visit 4 (4-6 months))
- Manifest Refraction(Visit 4 (4-6 Months))
- Uncorrected Distance Visual Acuity(Visit 3 (2-3 months) Visit 4 (4-6 months))
- Best-corrected Distance Visual Acuity(Visit 3 (2-3 months) Visit 4 (4-6 months))
- Mesopic Monocular Contrast Sensitivity With Glare 6 Cycles/Degree(Visit 4 (4-6 months))
- Binocular Mesopic Contrast Sensitivity Without Glare 1.5 & 3 Cycles/Degree(Visit 3 (2-3 months))
- Binocular Mesopic Contrast Sensitivity Without Glare 6 Cycles/Degree(Visit 3 (2-3 months))
- Binocular Mesopic Contrast Sensitivity Without Glare 12 Cycles/Degree(Visit 4 (4-6 months))
- Binocular Mesopic Contrast Sensitivity Without Glare 18 Cycles/Degree(Visit 4 (4-6 months))
- Binocular Mesopic Contrast Sensitivity Without Glare 1.5, 3, 6 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Monocular Contrast Sensitivity With Glare 1.5 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Monocular Contrast Sensitivity With Glare 3 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Monocular Contrast Sensitivity With Glare 12 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Monocular Contrast Sensitivity With Glare 18 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Binocular Contrast Sensitivity With Glare 1.5, 3 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Binocular Contrast Sensitivity With Glare 6 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Binocular Contrast Sensitivity With Glare 12 Cycles/Degree(Visit 4 (4-6 months))
- Mesopic Binocular Contrast Sensitivity With Glare 18 Cycles/Degree(Visit 4 (4-6 months))
- Optical Scatter(Visit 4 (4-6 months))