Project Bidof - Achieving Hybrid Monovision by Pairing Bifocal and EDOF Lens Technology
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Distance Visual Acuity
研究概览
简要总结
Modern day cataract surgery isn't just a rehabilitative procedure anymore but rather aims at improving a patient's quality of life by reducing the need for spectacles in everyday life to a minimum. One way of achieving this goal is by using different lens technologies, such as a mono- or bifocal lens paired a lens with EDOF technology, as EDOF lenses provide an enhanced depth of focus by creating a single elongated focal point. As this method is well established, the aim of this study is to compare the monofocal/EDOF cohort to the bifocal/EDOF cohort and evaluate visual acuity and patient satisfaction for both combinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21 and 99 years
- •signed informed consent form
- •condition after cataract surgery
排除标准
- •no signed informed consent form
- •laser treatment of the Cornea
- •macular pathologies
- •corneal pathologies
- •irregular astigmatism
- •pregnancy
结局指标
主要结局
Distance Visual Acuity
时间窗: 6 months
percentage of patients with binocular distance corrected visual acuity of logMAR \> 0.2
Intermediate Visual Acuity
时间窗: 6 months
percentage of patients with binocular intermediate distance corrected visual acuity of logMAR \> 0.2
Near Visual Acuity
时间窗: 6 months
percentage of patients with binocular near visual acuity logmar \< 0.2
次要结局
- contrast vision(3 months)
- Halo and Glare(3 months)
- Defocus curve(3 and 6 months)
研究者
Matthias Bolz
Head of Ophtalmology
Johannes Kepler University of Linz