Clinical Evaluation of a New Aspheric Intraocular Lens. A Prospective, Multi-Center, Comparative Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Low Contrast Best Corrected Visual Acuity Following Cataract Surgery
研究概览
简要总结
This study evaluates the visual performance and occurrence of posterior capsular opacification after implantation of a new aspherical intraocular lens compared with a control spherical lens of otherwise identical design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a clinically documented diagnosis of bilateral cataract (either cortical, nuclear, subcapsular or a combination) liable to benefit from standard cataract surgery.
- •Patients must be undergoing primary cataract surgery with IOL in-the-bag implantation, requiring a IOL power from 10 to 30 diopters.
排除标准
- •Patients with corneal damage.
- •Patients with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
- •Patients with any ocular pathology, other than the cataract, having repercussions on visual function:
研究组 & 干预措施
Advanced Akreos Adapt
Advanced Akreos Adapt Aspheric Intraocular Lens (IOL).
干预措施: Advanced Akreos Adapt in one operated eye. (Device)
Akreos Adapt
Akreos Adapt Spherical Intraocular Lens (IOL).
干预措施: Akreos Adapt in fellow operated eye. (Device)
结局指标
主要结局
Low Contrast Best Corrected Visual Acuity Following Cataract Surgery
时间窗: 3 months
Low contrast best corrected visual acuity (ability to distinguish objects on a similarly colored or shaded background) 3 months following cataract surgery.
Low Contrast Uncorrected Visual Acuity Following Cataract Surgery
时间窗: 3 months
Low contrast uncorrected visual acuity 3 months post cataract surgery
Photopic Contrast Sensitivity
时间窗: 3 months
The mean photopic (day light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)
Mesoptic Contrast Sensitivity
时间窗: 3 Months
The mean mesoptic (low light) contrast sensitivity for each spatial frequency (cycle per degree-CPD) (1.5, 3.0, 6.0, 12.0 and 18 cpd)
Posterior Capsule Opacification Score
时间窗: 24 months
Posterior Capsule Opacification Score (PCO), Density of opacification measured from 0-4 (1=minimal and 4=severe) and area of opacification measured from 0-1 (0=no opacification and 1=posterior capsule opacification required a treatment). Results (EPCO) were computer calculated by multiplying density by area of opacification.
次要结局
- High Contrast Visual Acuity(12 months)
- High Contrast Visual Acuity Uncorrected(24 Months)
- High Contrast Visual Acuity Best Corrected(24 Months)
- Low Contrast Visual Acuity(1 month)
- Contrast Sensitivity Photopic 1.5cpd(1 month)
- Contrast Sensitivity Photopic(1 month)
- Contrast Sensitivity Mesoptic 1.5 Cpd(1 month)
- Contrast Sensitivity Mesoptic(1 month)
- Posterior Capsule Opacification(12 months)
- High Contrast Visual Acuity(1 month)
- High Contrast Visual Acuity Uncorrected(3 months)
- High Contrast Visual Acuity Best Corrected(3 months)