Prospective Clinical Study to Evaluate Usability of Mesotest II for Assessment of Night Driving Capacity of Pseudophakic Patients Implanted With Monofocal IOL *AT.Smart 46LC
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
研究概览
简要总结
Pilot study to evaluate usability of Mesotest II for assessment of night driving capacity of pseudo-phakic patients implanted with aspheric monofocal posterior chamber IOL *AT.Smart 46LC.
Target Criterion:
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy eyes with cataract
- •Patient age 50-75 years
- •Written Patient Informed Consent
- •Assured follow-up examination
排除标准
- •Any kind of macula degeneration and impairment of retina (clinical diagnosis)
- •Amblyopia
- •Intraoperative complications; damaged posterior bag; intraocular haemorrhage
- •Astigmatism > 1.5 D (objective, preoperative)
- •Pregnancy or lactation period for female patients
研究组 & 干预措施
*AT.Smart 46LC
The *AT.Smart 46LC is indicated for primary implantation for the visual correction of aphakia in persons in whom the cataractous lens has been removed by phacoemulsification extracapsular cataract extraction. The IOL is intended to be placed only in an intact capsular bag. When implanted, the *AT.Smart 46LC replaces the natural lens of the eye and functions as a refracting medium in the correction of aphakia.
干预措施: *AT.Smart 46LC (Device)
结局指标
主要结局
Measurement of contrast sensitivity and sensitivity to light under mesopic conditions (Mesotest II, Oculus).
时间窗: 8 months
次要结局
未报告次要终点